Research methodology for ayurveda MD/MS

2. 2 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. INDEX S.No CHAPTERS PAGE NO 1. INTRODUCTION TO RESEARCH 3 2. GENERAL GUIDELINES & STEPS IN THE RESEARCH PROCESS 12 3. PREPARATION OF RESEARCH PROPOSALS 56 4. SCIENTIFIC WRITINGS & PUBLICATION SKILLS 59 5. CLASSICAL METHODS OF RESEARCH 67 6. COMPARISON BETWEEN MEHTODS OF RESEARCH 72 7. DIFFERENT FIELDS OF RESEARCH IN AYURVEDA 74 8. LITERARY RESEARCH 75 9. DRUG RESEARCH 77 10. SAFETY ASPECT 109 11. INTRODUCTION TO LATEST TRENDS IN DRUG DISCOVERY & DRUG DEVELOPMENT 115 12. CLINICAL RESEARCH 117 13. PHARMACOVIGILANCE FOR ASU DRUGS 126 14. INTRODUCTION TO BIOINFORMATION 134 15. INTELLECTUAL PROPERTY RIGHT 140

3. 3 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. DEDICATED TO ‘’LALTERN’’ 1. INTRODUCTION TO RESEARCH A. DEFINITION OF THE TERM RESEARCH The word research Re = means, once more, afresh, anew OR Back; with return to a previous state Search = look thorough or go over thoroughly to look something) OR Examine to find anything concealed Research is composed of two syllables “re” and “search”. “Re ” is a prefix meaning again or over again. “Search ” is a verb meaning to examine, to test and try or to probe closely and carefully. = Together they form a noun describing a careful, systematic, patient study and investigation in some field of knowledge, undertaken to establish facts or principles. - (Grinnell 1993). Who always Enlightened & Motivated Me, to the path of success.

4. 4 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Research is a voyage of discovery or a journey from the known to unknown.  According to Goddard & Melville (2004), answering unanswered questions or exploring which currently not exist is a research.  The Advanced Learner’s Dictionary of current English lays down the meaning of research as a careful investigation or inquiry especially through search for new facts in any branch of knowledge. 1. Define Research problem 2. Review Literature 3. Formulate Hypothesis 4. Design Research Including Sample design 6. Analysis of data/ test Hypothesis 5. Collection of data 7. Interpret & report

5. 5 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Redmen & Mory (2009), define research as a systematized effort to gain new knowledge.  A/C to Neuman A collection of methods and methodologies that researchers apply systematically to produce scientifically based knowledge about the social world. • The systematic and rigorous process of inquiry that aims to describe processes and phenomena, and to develop and test explanatory concepts and theories, in order to contribute to a scientific body of knowledge (e.g. improve health, health outcomes and health services). • Research must be systematic and follow a series of steps and a rigid standard protocol. These rules are broadly similar but may vary slightly between the different fields of science. • Methodology: Methodology & methods, two terms are often treated as synonyms. Methodology is broader and envelops methods. It is understanding the social-organizational context, philosophical assumptions, ethical principles and political issues of the enterprise of researchers who use methods. • Methods: Methods are set of specific techniques for selecting cases, measuring and observing aspects of social life, gathering and refining data, analyzing data and reporting on results.

6. 6 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. To summarize Research is an ORGANIZED and SYSTEMATIC way of FINDING ANSWERS to QUESTIONS. SYSTEMATIC Because there is a definite set of procedures and steps which you will follow. There are certain things in the research process which are always done in order to get the most accurate results. ORGANIZED In that there is a structure or method in going about doing research. It is a planned procedure, not a spontaneous one. It is focused and limited to a specific scope. FINDING ANSWERS Is the end of all research? Whether it is the answer to a hypothesis or even a simple question, research is successful when we find answers. Sometimes the answer is no, but it is still an answer. QUESTIONS Are central to research. If there is no question, then the answer is of no use. Research is focused on relevant, useful, and important questions. Without a question, research has no focus, drive, or purpose.

7. 7 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Definition of health research • The process for obtaining systematic knowledge and technology which can be used for the improvement of the health of individual and groups. • Descriptive investigations of the experience of illness and people’s perceptions of health and ill health. • It focuses on the basic information on the state of health and disease of the population. Health Services Research • It focuses on the evaluations of relationship between the appropriateness, effectiveness and efficiency of health services and the health needs of the population. • It investigates the outcome of health services or medical interventions from psychological, physical, economic and social perspectives. • Health services research is a multidisciplinary field of inquiry, both basic and applied, that examines how social factors, financing systems, organizational structures and processes, health technologies, and personal beliefs and behaviors affect access to and utilization of healthcare, the quality and cost of healthcare, and in the end our health and well-being. Ultimately, the goals of health services research are to identify the most effective ways to organize, manage, finance, and deliver high quality care. Alternative to Research • Authority When you accept something as true just because someone in a position of authority says it is true or it is an authoritative publication, you are using authority as basis of knowledge eg. Parents, Teachers, Books.

8. 8 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. • Tradition Tradition is a special case of authority-the authority of the past. It means you accept something as being true because “it’s the way things have always been. • Common sense You rely on what everyone knows and what “just makes sense”. It is about ordinary reasoning. It can originate from tradition • Media myths Media tends to perpetuate the myths of a culture. • Personal experience If something happens to you, if you personally experience it or see it, you accept it as true.

9. 9 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Types of Research 1. Quantitative Research 1.Comparative Research 2. Basic Research 2.Explorative Research 3. Applied Research 3.Explanatory Research 4. Longitudinal Research 4. Causal Research 5. Qualitative Research 5. Theory-testing Research 6. Descriptive Research 6. Theory-Building Research 7. Classification Research 7.Action Research Qualities of good research  Systematic  Controlled  Logical  Empirical  Replicable  Self-correcting

10. 10 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. b. DEFINITION OF TERM ANUSANDHAN अनु = to follow संधान= appropriate knowledge Thus, अनुसंधान means to follow appropriate knowledge. A/C to P.V. Sharma, the study of cause & effect relationship between द्रव्य, गुण & कर्म after several observations & through verifiable examinations, arrival at final conclusion is called अनुसंधान. “कायमकारणभवाष्य द्रव्याणां गुणकर्मयो:| परीक्ष्य स्थापनं सम्यक् अनुसंधानर्् उच्यते ||” Synonyms  अनुसंधान  शोध  गवेषण = to search or to achieve with the help of all senses.  अन्वेषण =desire to search.  पयमषण = to search from all the dimensions.

11. 11 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. c. Need Of Research In The Field Of Ayurveda RESEARCH especially in clinical field is essential for  Revalidation of facts illustrated in Ayurveda classics.  To find out better treatment for existing diseases and for newer diseases.  To standardize clinical /treatment procedure scientifically.  To establish dose, indication and side effect profile for any given drug.  The terms of Ayurveda Rachana sarira like KLOMA, KALA etc. needs clarifications which can be brought about by fundamental research.  CONCEPTUAL RESEARCH, Reinterpretation of nonfigurative ideas (abstract) Eg:-Research conducting on the concept of Tridoshas.  Analytical-Critically evaluating the facts – why the particular? Here a relationship (association) between a ‘risk factor’ (etiological agent) and an outcome (disease) establishing is the primary goal. Research in field of Ayurveda drug  To standardize Ayurveda raw drugs.  To standardize drug – dose/ administration time.  To standardize drug manufacturing process.  To standardize final product.  To identify & standardize the controversial drugs in Ayurveda.  To formulate new drugs from Ayurveda texts & prove their efficiency.

12. 12 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Research in field of Ayurveda Literary  Collection of critical revised edition of available manuscripts.  Cataloguing of original manuscripts related to Ayurveda.  Classification of the available ancient Sanskrit literature related to Ayurveda.  The traditional facts & theories can be re- examined & re-evaluated .Their validity should be re- stabilized scientifically.  To put forth practical applications of basic principles. Research in field of clinical research in Ayurveda  To assess the results of different types of Ayurveda treatments given in classical texts.  To search etiological factors with Ayurveda perspective for various disease.  Evaluation of Ayurveda therapies on basis of their effects & side effects.  Conducting clinical trials with integral approach. GOOD RESEACH TOPIC Criteria is “FINER” F-Feasibility- easy to do or can done easily. I-Interest- desire to learn N- Novelty- quality of being new, different &interesting E-Ethics - study of moral principles. R-Relevance- related with current situation.

13. 13 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 2. GENERAL GUIDELINES & STEPS IN THE RESEARCH PROCESS a. Selection of the Research Problem DEFINITION According to Kerlinger, ‘A problem is an interrogative sentence or statement that asks what relation exists between two or more variable. The answer to question will provide what is having sought in the research. R.S. Woodworth defines problem as ‘a situation for which we have no ready and successful response by instinct or by previous acquired habit. We must find out what to do’, i.e. the solution can be found out only after an investigation. Wipro CEO wants to launch its company in Mysore? He is in a process of Decision Making Decision making Needs… Conviction There should be Knowledge to Goal achievement No doubts? Justify your decision

14. 14 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. What is selection??? A good research title should be • Simple : not complicated • Attractive: draw the attention of readers • Concise: not long • Clear: able to tell the key research objective (or what it is expected to say) • Complete and focused: reflect the scope of work exactly • Short: Generally one line The term methodology refers to the overall approaches & perspectives to the research process as a whole and is concerned with the following main issues: Why you collected certain data? What data you collected? Where you collected it? How you collected it? How you analyzed it? - (Collis & Hussey, 2003, p.55).

15. 15 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Basic study steps for Research  State the problem (what are the questions?)  Devise a plan of action (what will I do?)  Implement the plan (how I do it?)  Analyze data (what happened?)  Interpret data (what does this mean?)  Re-examination (is my logic correct? What next?) Identification of Research Problem Identify the Research Problem Review the Literature Specify a Research Purpose Collect Data Report And Evaluate Research Analyze and Interpret Data

16. 16 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Guidelines in the Selection of a Research Problem Definition the Title Hypothesis Assumptions Statements of the Problems Elements of the research

17. 17 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Selecting a research problem  Finding a suitable research topic can be difficult!  Not every questions or problems that interest you can be a research problem. Research problems are selected based on 6 criteria as discussed by Sethaput (1993). 1. Interest It is a first priority in setting the problems. Why??? However, the background of researcher and advisor are also importance. 2. Urgency This criteria is related to the type and size of the population in which the problem is found, its scope and effects, the number of people impacted and the immediate need for solutions. 3. Usefulness There are two main areas of usefulness. i). to expand knowledge and information. ii). to find solutions to problems or obstacles. 4. Ability The researcher’s own ability, educational and philosophical background, technical capabilities, research method knowledge as well as the ability to review the literature on a problem and synthesize out the importance points. 5. Uniqueness of your research The research should be unique to avoid answering the same questions and thus wasting research resources and ruining the researcher’s reputation. 6. Practical limitations/feasibility Time, cost, access to resources, approval of authorities, ethical concerns and expertise.

18. 18 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Sources of Problem  Reading – Research reports  Academic Experience – Classroom Lectures, class discussions, seminar discussions & out of class exchanges of ideas with fellow students & professors.  Daily Experience – Eg.: Story of Newton  Exposure to field situations – Field visits, Internship training  Consultations – Discussions with experts, researchers, administrators & business executives.  Brain storming – Intensified discussion within a group of interested persons.  Research – Research on one problem may suggest problems for further research.  Intuition- New ideas may strike to one’s mind like a flash. Internal • Researcher’s Interest The problem should interest the researcher and be a challenge to him. Without interest and curiosity, he may not develop sustained perseverance. Interest in a problem depends upon the researcher’s educational background, experience, etc. • Researcher’s competence

19. 19 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. The researcher must be competent to plan and carry out a study of the problem. He must have the ability to grasp and deal with it. He must possess adequate knowledge of the subject matter, relevant methodology and statistical procedures. • Researcher’s own resource: finance & time. Financial resource & Time resource External • Research ability of the problem • Importance & Urgency • Novelty of the problem • Feasibility • Facilities • Usefulness & Social Relevance • Research Personnel Feasibility –  A problem may be a new one and also important, but if research on it is not feasible, it cannot be selected.  Some of the questions that should be considered in examining the feasibility are: Are suitable research techniques such as measurement devices and techniques of analysis available?  Are accurate and reliable data available?  Reliability depends upon quality of data. Will the authorities of the concerned institutions extend the required data or permit to access to records?  Will the respondents be willing to be interviewed?  Can the study be completed within the time available? Facilities –

20. 20 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Researcher requires certain facilities such as well-equipped library facility, suitable and competent guidance, data analysis facility, etc.  Usefulness & social relevance – The study of the problem should make significant contribution to the concerned body of knowledge or to the solution of some significant practical problem.  Research Personnel – Research undertaken by professors and by research organizations require the services of investigators and research officers. To sum up  The first & foremost step is the statement of research problem; one intends to take for the proposed study. Research problem should be precise & clear without any confusion, so that a neat proposal/ synopsis can be made out of it.  As for as possible, the problems should be need based & relevant to the current times.  Researchers should define it well, stress its importance, prevalence & lacuna if any in the current understanding & how the research is beneficial to current society.  The problems should be specific one so that it can be focused well in the intended research.  While choosing the research problem pertaining to different specialties of Ayurveda, the priority areas of research as indicated by CCRAS should be consulted.  P.G. scholars who are selecting the research problems for their proposed study, should discuss with their guide, co-guide, & teachers about the feasibility of the study & problems likely to arise during research process.

21. 21 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. b. Literature review: different methods (including computer database) with their advantages & limitations. Definition •Review is a formal assessment of something with the intention of instituting change if necessary. A/c to University of Wisconsin Writing Center, A literature review is a “critical analysis of a segment of a published body of knowledge through summary, classification, and comparison of prior research studies, reviews of literature, and theoretical articles”. Why do we review literature? • To know more about a problem • To avoid duplication of information • To learn the gaps in the arena of study • To learn various methods that others used • To forecast challenges that might be faced in the conduct of study What do we review? (Sources) • Library (published information) • Electronic search engines (internet) • Gray literature (Unpublished ones)

22. 22 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. The literature review process How do we write a review of literature? Three steps in writing review of literature • Consider your analysis of the problem • Organize notes based on factors • Decide the order (you have three options) – From broader to specific – From global to local – From past to present Importance of Literature Review 1. A literature review may be an end in itself to publish it as a review 2. It can be a preparatory work for taking up / motivating future research 3. It can be to choose and formulate a research problem (more appropriately called as ‘literature survey’) 4. Literature Review enables a researcher to become an expert/ specialist/ authority in the specific area; the expertise acquired is often directly proportional to the efforts put in literature review 1.Select a topic 2.Search & choose the literature 3.Analyse & interpret the literature 4. write the review

23. 23 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Use of Computer •It is even better idea to organize categorical information in a database. Once computer is set up, finding, updating and adding new information becomes quite easy; Software’s like Note Scribe, EndNotesand EverNote help a lot •For references to be used for citation and bibliography, a number of software’s like ‘Reference manager’, ‘Librarian’, etc., make it easy and accurate to produce in whichever style they are required later once data is entered completely and correctly. •There are online personal libraries like that of ResearchGate, Mandeley, Colwizand Google Scholar, Medline, Up-to-Date, etc where in you can build references of your own and other publications; they can later be imported and exported from one to the other in Bibtex, Refworksand Endnote formats. references collected sources skimmed sources selected

24. 24 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. c. Formulation of Hypothesis One-way arrow: Cause-effect relationships Two-way arrows: Mutual relationships Core problem: Drawing a double line around it

25. 25 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. A Complete Problem Analysis Diagram

26. 26 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Role of hypothesis  It serves as a chain between theory and investigation  It helps in holistic study as its links facts and information together.  It prevents blind research. Types of Hypothesis 1. Descriptive hypothesis 2. Relational hypothesis 3. Null hypothesis Formulating a hypothesis 1. There should not be any haphazard guesses but it should reflect the depth of knowledge, imagination and experience of researcher. 2. We construct hypothesis by exact observation of available data and suggestions from expert. 3. A useful hypothesis is a testable statement, which may include a prediction. (Testable - By means of test, how two variables might be related should be find out.) 4. The originality and logic –with which hypothesis are formulated are important. 5. A hypothesis is based on some previous observation. Eg. In November many trees undergo color changes in their leaves and the average daily temperatures are dropping. (Are these two events connected? How to formulate a hypothesis?)

27. 27 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. d. Defining General & Specific Objectives. General Objectives  They are broad goals to be achieved  It explains what the researcher expects to achieve by the study in general terms.  They are usually less in no.  General objectives are met through accomplishing all specific objectives. Eg. To assess the effects of ginger on morning sickness among pregnant women Specific objectives  They are short term and narrow in focus.  Specific objectives are more in no.  They systematically addresses various aspects of the problem as defined under the “STATEMENT OF THE PROBLEM”. It also address the key factor that is assumed to influence or cause the problem. Eg. 1. To compare the effect of ginger in primi and multi gravidae. 2. To compare the effectiveness of ginger on morning sickness in working women and non-working women. Criteria for setting research objectives Research objectives should be • Focused, each covering a single point • Ordered in a logical sequence • Realistic and feasible to answer • Operational using action-verbs • Measurable in terms of outcomes at the end

28. 28 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Action-verbs Vs non-action verbs Action-verbs To determine To compare To verify To calculate To describe To asses To explore To test To establish To identify Non-action verbs To appreciate To understand To show To share To believe to study Short Objectives must be SMART Specific Measurable Achievable Realistic Time-bound e. Research design: Definition Research design can be defined as a blue print to conduct a research study which involves the description of research approach, study setting, sampling size, sampling technique, tools and methods of data

29. 29 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. collection and analysis to answer a specific research question or for testing research hypotheses. Research design is a plan of how & where data are to be collected & analyzed. Types a. True- Experimental Design 1. Experimental design b.Quasi Experimental Design 2. Non- Experimental design c. Pre - experimental Design 3. Others/ Additional Design Quantitative Research Design Qualitative Research Design

30. 30 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Study designs four major study designs • Cross-sectional • Case-control • Cohort • Experimental Selection of the study design depends on the objective of a study

31. 31 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. f. Sample Design  A sample design is a definite plan for obtaining a sample from a sample frame or given population.  Sample design is determined before data is collected.  There are many sample designs from which the researcher can choose which is apt for his/ her study. STEPS IN SAMPLE DESIGN 1. Define the Population 2. Source List 3. Sampling Unit 4. Specify Sampling Method of Measurement 5. Size of Sample 6. Budgetary Constraints 7. Sampling Procedure SAMPLING ERRORS Sampling errors are those errors which arise an account of sampling and they generally happen to be random variations in the sample, estimates from the true population values In general – Sampling errors = frame error + chance error + response error CHARACTERISTICS OF GOOD SAMPLE DESIGN  It must result in truly representative sample  It must be such which results in a small sampling error  Be viable in the context of funds available for research study.  Be in such a way that systematic bias can be controlled. SAMPLING CLASSIFICATION 1. PROBABILITY SAMPLING  Simple random sampling,  Stratified random sampling,

32. 32 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  systematic random sampling,  Cluster random sampling,  Multi stage and  Multi phase sampling. 2. NON –PROBABILITY SAMPLING  sampling,  quota sampling  snowball sampling, theoretical sampling,  Voluntary sampling etc. g. Collection of the data  Derived from Latin language.  Datum (singular) – Data (plural).  Any collection of facts of figures.  The raw material to be processed by a computer.  It is Plural form of word Datum.  It means –information that is systematically collected in the courses of study. Signals Process Information Data is a set of signals which will be converted into information after processing properly

33. 33 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Need of Data  It serve as the bases or raw materials for analysis.  Without analysis of actual data no specific inferences can be drawn on the research question  The relevance, adequacy and reliability of data determine the quality of the findings of the study.  It forms the basis for testing the hypotheses formulated in the study.  Data provides facts and figures required for the analysis using statistical techniques. Types of data Nature of Data Qualitative Quantitative Sources of Data Primary Secondary Origin of Data Household, Community, Health Facilities (SHPs, HPs, PHCCs, Hospitals) Private Clinics, Laboratory, Etc. OR

34. 34 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Types of data 1. Primary data 2. Secondary data Those which are collected those which have already been A fresh and for the first time. Collected by someone else, and  i) Observation method have already been passed ii) Interview method through statistical analysis  iii) Questionnaires iv) Schedules Other methods includes a) Warranty cards b) Distributor audits c) Pantry audits d) Depth interviews etc. h) Analysis of data Analysis of one or two or more than two variables (Qualitative or Quantitative) at a time.  After the data has been collected, the researcher has the task of analyzing them. The analysis of data requires a number of related operations such as; creating raw data through tabulation pie-charts, coding & then drawing statistical inferences.

35. 35 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  The term analysis refers, to the computation of certain measures along with searching of patterns of relationships that exist among data groups.  Types of Analysis – 2 » Descriptive analysis » Inferential analysis. Purpose of Data Analysis • To convert the Data into usable information • To remove the effects of Confounding variables • To test hypothesis that allow the investigator to draw conclusions • To measure the size of the differences between groups or the strengths of the relationship between variables found in the study The important steps in analysis of data are 1. Coding 2. Editing 3. Tabulation 4. Use of computers. i) Generalization & interpretation , Evaluation & Assessment of Hypothesis Generalization & Interpretation – In this stage, hypothesis is compared by testing various statistical tools such as Chi-square test, F test, T test. Any test may be applied depending upon the nature & object of the research hypothesis. Testing will result in either accepting or rejecting the hypothesis.

36. 36 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. INTERPRETATION IN RESEARCH METHODOLOGY INTRODUCTION Data interpretation is part of daily life for most people. Interpretation is the process of making sense of numerical data that has been collected, analyzed, and presented. A common method of assessing numerical data is known as statistical analysis, and the activity of analyzing and interpreting data in order to make predictions is known as inferential statistics . After collecting and analyzing the data, the researcher has to accomplish the task of drawing inferences followed by report writing. Only through interpretation that the researcher can expose relations and processes that underlie his findings. All this analytical information and consequential inference(s) may well be communicated, preferably through research report, to the consult of research results who may be either an individual or a group of individuals or some public private organization. MEANING OF INTERPRETATION: MEANING OF INTERPRETATION refers to the task of drawing inferences from the collected facts after an analytical and or experimental study. In fact, it is a search for broader meaning of research findings. The task of interpretation has two major aspects viz., the effort to establish continuity in research through linking the results of a given study with those of another, and the establishment of some extraordinary concepts. “In one sense, interpretation is concerned with relationships within the collected data, partially overlapping analysis. Interpretation also extends beyond the data of the study to inch the results of other research, theory and hypotheses. ”

37. 37 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Technique of Interpretation: Technique of Interpretation often involves the following steps: (i) Researcher must give reasonable explanations of the relations which he has found and he must interpret the lines of relationship in terms of the underlying processes and must try to find out the thread of uniformity that lies under the surface layer of his diversified research findings. (ii) Extraneous information, if collected during the study, must be considered while interpreting the final results of research study, for it may prove to be a key factor in understanding the problem under consideration. (iii) Consultation will result in correct interpretation and, thus, will enhance the utility of research results. (iv) Researcher must accomplish the task of interpretation only after considering all relevant factors affecting the problem to avoid false generalization. EVALUATION & ASSESSMENT OF HYPOTHESIS Hypothesis testing is a procedure used to obtain an answer, on basis of information from sample observation. In simple words hypothesis testing is a process of deciding statistically whether the findings of an investigation reflects chance or real affect at given level of probability. Thus hypothesis is testing is based on the application of probability theory & sampling.

38. 38 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. PROCEDURE FOR TESTING HYPOTHESIS  Set up the null hypothesis (Ho)  Check any necessary assumptions and write null and alternative hypotheses.  Calculate an appropriate test statistic.  Determine a p-value associated with the test statistic.  Decide between the null and alternative hypotheses.  State a "real world" conclusion. 5 STEPS IN THE HYPOTHESIS TESTING PROCEDURE 1. State the null hypothesis and the alternate hypothesis. Null Hypothesis – statement about the value of a population parameter. Alternate Hypothesis – statement that is accepted if evidence proves null hypothesis to be false. 2. Select the appropriate test statistic and level of significance. When testing a hypothesis of a proportion, we use the z-statistic or z-test and the formula n pq p p z − = ˆ When testing a hypothesis of a mean, we use the z-statistic or we use the t-statistic according to the following conditions. If the population standard deviation, σ, is known and either the data is normally distributed or the sample size n > 30, we use the normal distribution (z-statistic). When the population standard deviation, σ, is unknown and either the data is normally distributed or the sample size is greater than 30 (n > 30), we use the t-distribution (t-statistic).

39. 39 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. A traditional guideline for choosing the level of significance is as follows: (a) the 0.10 level for political polling, (b) the 0.05 level for consumer research projects, and (c) the 0.01 level for quality assurance work. 3. State the decision rules. The decision rules state the conditions under which the null hypothesis will be accepted or rejected. The critical value for the test-statistic is determined by the level of significance. The critical value is the value that divides the non-reject region from the reject region. 4. Compute the appropriate test statistic and make the decision. When we use the z-statistic, we use the formula n x z σ − µ = When we use the t- statistic, we use the formula n s x t − µ = Compare the computed test statistic with critical value. If the computed value is within the rejection region(s), we reject the null hypothesis; otherwise, we do not reject the null hypothesis. 5. Interpret the decision. Based on the decision in Step 4, we state a conclusion in the context of the original problem.

40. 40 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. NULL HYPOTHESIS  The test is designed to assess the strength of the evidence against Ho.  It is denoted by H0 H0：m =one value ALTERNATIVE HYPOTHESIS  It is corresponding to null hypothesis  It is denoted by H1 H1：m <one value or m >one value  H1 is a statement of the alternative we will accept if the evidence enables us to reject Ho, so H1 is called alternative hypothesis, it is opposite to Ho, and it is often the conclusion what the researcher hope to obtain. CONFIRM SIGNIFICANT LEVEL a  It is a probability value (the probability of rejecting a true null hypothesis)  It is denoted by α (alpha). Generally, αis 0.01 or 0.05.  It is determined by the investigator in advance. DETERMINE THE APPROPRIATE T.S The selection of test statistics is related with the study aims and conditions proffered by the sample. FIND THE P-VALUE AND DRAW CONCLUSION  The mathematician have calculated probability corresponding to every T.S, and listed in some tables. This is the probability that the test

41. 41 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. statistic would weigh against Ho at least as strongly as it does for these data. FIND THE P-VALUE AND DRAW CONCLUSION  If P≤α, we reject Ho in favor of H1 at significant level α, We may think that the two populations are different;  If P>α, we don`t reject Ho at significant level α. We may think that two populations are same. TYPEⅠERROR VERSUS TYPEⅡ ERROR IN HYPOTHESIS TEST  Because the predictions in H0 and H1 are written so that they are mutually exclusive and all inclusive, we have a situation where one is true and the other is automatically false.  when H0 is true ,then H1 is false.  If we accept H0 ,we have done the right decision.  If we reject H0 ,we have made an error.  This type of mistake is called a Type Ⅰ error .The probability of type Ⅰ error is α  when H0 is false ,then H1 is true.  If we accept H0 , we have made an error.  If we reject H0 , we have done the right thing.  This type of mistake is called a type Ⅱ error . The probability of type Ⅱ error is β , which is more difficult to assess because it depends on several factors. The probability of rejecting H0 when it is, in fact, false is 1- β and is called the power of the test.

42. 42 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. TWO-SIDED TEST AND ONE-SIDED TEST 1 Two-sided test Consider two kinds of site relation while inferring whether two populations are different. 2 One-sided test： only consider one kind of site relation while inferring whether two populations are different.

43. 43 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.

44. 44 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.

45. 45 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. When the assumption of normal distribution is violated, we should make data transformation or choose rank sum test.  When the assumption of normal distribution is valid while the homogeneity of variance is violated , we should choose correction t test (ť test)  When the assumption of normal distribution is violated, we should choose rank sum test.

46. 46 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 2.3 PAIRED-SAMPLES ť TEST  assumptions The differences among each paired-samples must come from normal distribution population.  When the assumption of normal distribution of difference is violated, we should make data transformation or choose rank sum test

47. 47 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. J. ETHICAL ASPECTS RELATED TO HUMAN EXPERIMENTS The Declaration of Helsinki (DoH) is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the: 29th WMA General Assembly, Tokyo, Japan, October 1975 35th WMA General Assembly, Venice, Italy, October 1983 41st WMA General Assembly, Hong Kong, September 1989 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added) 55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added) 59th WMA General Assembly, Seoul, October 2008 A. INTRODUCTION 1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. The Declaration is intended to be read as a whole and each of its constituent paragraphs should not be applied without consideration of all other relevant paragraphs. 2. Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles. 3. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty. 4. The Declaration of Geneva of the WMA binds the physician with the words, “The health of my patient will be my first consideration,” and the International Code of Medical Ethics declares that, “A physician shall act in the patient's best interest when providing medical care.” 5. Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research. 6. In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.

48. 48 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 7. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality. 8. In medical practice and in medical research, most interventions involve risks and burdens. 9. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence. 10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration. B. PRINCIPLES FOR ALL MEDICAL RESEARCH 11. It is the duty of physicians who participate in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. 12. Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected. 13. Appropriate caution must be exercised in the conduct of medical research that may harm the environment. 14. The design and performance of each research study involving human subjects must be clearly described in a research protocol. The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest, incentives for subjects and provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. The protocol should describe arrangements for post-study access by study subjects to interventions identified as beneficial in the study or access to other appropriate care or benefits. 15. The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This committee must be independent of the researcher, the sponsor and any other undue influence. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any

49. 49 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. serious adverse events. No change to the protocol may be made without consideration and approval by the committee. 16. Medical research involving human subjects must be conducted only by individuals with the appropriate scientific training and qualifications. Research on patients or healthy volunteers requires the supervision of a competent and appropriately qualified physician or other health care professional. The responsibility for the protection of research subjects must always rest with the physician or other health care professional and never the research subjects, even though they have given consent. 17. Medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community and if there is a reasonable likelihood that this population or community stands to benefit from the results of the research. 18. Every medical research study involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and communities involved in the research in comparison with foreseeable benefits to them and to other individuals or communities affected by the condition under investigation. 19. Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject. 20. Physicians may not participate in a research study involving human subjects unless they are confident that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefits or when there is conclusive proof of positive and beneficial results. 21. Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects. 22. Participation by competent individuals as subjects in medical research must be voluntary. Although it may be appropriate to consult family members or community leaders, no competent individual may be enrolled in a research study unless he or she freely agrees. 23. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information and to minimize the impact of the study on their physical, mental and social integrity. 24. In medical research involving competent human subjects, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information. After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. 25. For medical research using identifiable human material or data, physicians must normally seek consent for the collection, analysis, storage and/or reuse. There may be situations where

50. 50 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. consent would be impossible or impractical to obtain for such research or would pose a threat to the validity of the research. In such situations the research may be done only after consideration and approval of a research ethics committee. 26. When seeking informed consent for participation in a research study the physician should be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent should be sought by an appropriately qualified individual who is completely independent of this relationship. 27. For a potential research subject who is incompetent, the physician must seek informed consent from the legally authorized representative. These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the population represented by the potential subject, the research cannot instead be performed with competent persons, and the research entails only minimal risk and minimal burden. 28. When a potential research subject who is deemed incompetent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorized representative. The potential subject’s dissent should be respected. 29. Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research population. In such circumstances the physician should seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee. Consent to remain in the research should be obtained as soon as possible from the subject or a legally authorized representative. 30. Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results should be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest should be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication. C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 31. The physician may combine medical research with medical care only to the extent that the research is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects. 32. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

51. 51 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. • The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or • Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option. 33. At the conclusion of the study, patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, for example, access to interventions identified as beneficial in the study or to other appropriate care or benefits. 34. The physician must fully inform the patient which aspects of the care are related to the research. The refusal of a patient to participate in a study or the patient’s decision to withdraw from the study must never interfere with the patient-physician relationship. 35. In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available. ETHICAL ASPECTS OF ANIMAL ETHICS (AEC) Experimentation on animals in course of medical research and education is covered by provisions of the Prevention of Cruelty to Animals Act, 1960 and Breeding of and Experiments on Animals (Control & Supervision) Rules of 1998, 2001 and 2006 framed under the Act. These are enforced by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), a statutory body under the Prevention of Cruelty to Animals Act, 1960. Institutional Animals Ethics committee- 8 members 1. A biological scientist, 2. Two scientists from different biological disciplines, 3. A veterinarian involved in the care of animal, 4. Scientist in charge of animals facility of the establishment concerned, 5. A scientist from, outside the institute, 6. A non-scientific socially aware member and 7. A nominee of CPCSEA

52. 52 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Specialist may be co-opted while reviewing special project using hazardous agents such as radio-active substance and deadly micro organisms  The Chairperson of the Committee and Member Secretary would be nominated by the Institution from amongst the eight members  Members against Serial number 5,6 and 7 will be nominated by CPCSEA, with a provision of a Link Nominee for CPCSEA nominee » The duration of appointment is for a period of 3 years Objectives : To take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them Animal experiments used to develop new medicines and to test the safety of other product. The 3 R’s are set of principles that scientist are encouraging to follow in order to reduce the impact of research on animals.  Reduction Reducing the number of animals used in experiments by » Improving experimental technique » Improving techniques of data analysis » Sharing information with other researchers.  Refinement: the way the animals are cared for so as to reduce their sufferings » Using less invasive techniques » Better medical care » Better living condition  Replacement: with alternative techniques » Experimenting on cell cultures instead of whole animals » Using computers models » Studying human volunteers » Using epidemiological studies

53. 53 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. The following ethical principles suggested by WHO- European union forum.  to considerably improve the welfare of animals used in scientific procedures Refer: http://www.wma.net/en/30publications/10policies/b3/17c.pdf INSTITUTIONAL ETHICS COMMMITTEE (IEC)  A formally designated group that oversees research involving human subjects. Approves and disapproves human subject research.  According to the standards of the community or the institution, the IRB/IEC may require modifications to a protocol to ensure patient safety. 17 Function •The primary function of an IRB/IEC is to safe guard the rights, safety ,and wellbeing of all trial subjects. This is accomplished by initial, continuing and annual review. •An IRB should consist of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. .  All studies must be approved prior to recruiting participants.  IRB must review all documents given to participants.  Reporting AEs and Deviations from protocol to the IRB.  Maintenance of Records.

54. 54 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Primary objective:  Right  Dignity  Safety  Well-being of participants Secondary objective  GCP compatibility  Publishing  Regulatory authority  Data exchange & acceptability between countries  Standard uniformity IRB Members 1. A minimum of five (5) members. 2. One member whose concern is not scientific. 3. One member who has no personal or familial relationship to the institution or trial site. 4. Any member with a conflict of interest may not participate in any part of the review or vote (except to provide requested information). 5. Individuals with special expertise may be invited to assist with areas of unique or complex nature. These will not be voting members. 6. A list of IRB/IEC members and their qualifications 19should be maintained OR Composition of IEC – 7 members minimum & maximum 7-12 Quorum of 5 Chairperson from outside  Chairperson  Clinical pharmacologist  One clinician  One layer/ judge

55. 55 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  One philosopher  One lay person  Members secretary Functioning  Justification & objective: if the prospect is to discover new ways of benefiting people’s health.  Scientific design: control arm, sample size, statically methods, criteria, benefits Vs Risk  Informed consent  Community consideration QUESTION’S??? 1. Discuss about declaration of Helsinki?

56. 56 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 3. PREPARATION OF RESERCH PROPOSALS IN DIFFERENT DISCIPLINES FOR SUBMISSION TO FUNDING AGENCIES TAKING EMR-AYUSH SCHEME AS MODEL AYURVEDA and SIDDHA Standardization of Ayurveda and Siddha Drugs, safety/toxicity studies, pharmacological studies, clinical trials, etc. under following priority areas/diseases: Clinical Research First priority  Life style related disorders  Metabolic disorders  Peptic ulcer  Psoriasis  Malnutrition  Reproductive Child Health (RCH) including infertility and contraceptives  Benign prostate enlargement  Preventive cardiology-hypertension, obesity  Urolithiasis  General Health Promotion Rasayana/Medhya Rasayana  Mental Health/memory relating disorders  Sports Medicine  Liver Disorders (Hepatitis B)  Primary health care relating issues  Malaria  Filarial  Rheumatoid arthritis  Menstrual disorder Reproductive tract infection  Cancer  Bronchial asthma, Upper respiratory tract infection  Neurological disorders Second priority:  Musculoskeletal disorders  Fever  Diarrhea (including dysentery)  Indigestion and anorexia  Skin Diseases  Eye and ENT Diseases  Secondary/tertiary health care relating issues Research on fundamental principles of AYUSH:  Pancha Mahabhutas – Tridosa

57. 57 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Prakriti, Agni, Srotas, Saptadhatu, Ojas, Ama etc.  Studies related to Pharmaco-dynamics kinetics e.g. Rasa, Guna, Virya, Vipaka and Prabhava  Surgical and para-surgical procedures  Similar areas of Siddha  Molecular Pharmacology  Genetics Identification and evaluation of promising and widely accepted practices and skills of traditional healers in rural and tribal areas Research on the preventive and promote aspects AYUSH practices and therapies Revival of ancient literature–Survey, collection, transcription / translation, editing and Publication of classical literature and text books, Medico-historical investigations of AYUSH Sample survey of contemporary requirements of AYUSH Issues relating to the use of Modern Technology to develop the Drugs of AYUSH and Efficacy, Safety, Standards etc. PROPOSAL • A research proposal is a document written by a researcher that provides a detailed description of the proposed program • Proposal is a marketing document to an funder • It is a legal and binding contract between PI, and funder  short term  definite objectives  well defined inputs and outputs  specifies objective realization within specified costs and quality 1. Title  Summary (Not more than 500 words)

58. 58 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 2. Introduction - need, problem statements, aims, and objectives  Background of Study (maximum 500 words)  Statement of the Problem and Rationale / Justification  General objectives  Specific objectives  Research Questions (if relevant)  Research Hypothesis (if relevant)  Research Design and Methodology  Research Method Qualitative ( ), Quantitative ( ), Combined ( ) 3. Rationale 4. Research method - means of objective realization 5. Work program – activities, time, resources, indicators and their evaluation norms 6. Budget Central Council for Research in Ayurveda and Siddha, (C.C.R.A.S.) 61-65, Institutional Area, Opposite ‘D’ Block, Janak Puri New Delhi-110058 Email: ccras_dir1@nic.in Fax: 011-28520748, 011-28525959 Ayurveda and Siddha Research proposal should be submitted on this address. The research proposal  First in the month of January and Second in the month of July Time line for Receipt of Application by the Research Councils  The applications would be received and processed in four quarters

59. 59 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Quarter Processing by the PEC Processing by SC I Feb. First week Feb. last week II May first week May last week III Aug. first week Aug. last week IV Nov. First week Nov. last week

60. 60 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 4. SCIENTIFIC WRITING & PUBLICATION SKILLS DIFFERENT TYPES OF REFERENCING & BIBLIOGRAPHY Reference There are no sources in the current document. – A list of sources we have cited in our text arranged in the order they appeared within the text. It is usually put at the end of our work but it can also appear as a footnote (at the bottom of the page), or endnote (at the end of each chapter) which serves a similar purpose. Bibliography – a separate list of sources we have consulted but not specifically cited in our work including background reading. It is arranged alphabetically by the author's surname. Difference between Reference List and Bibliography Referencing/Citation styles Some commonly used style manuals are…. 1. Publication Manual of the American Psychological Association (APA) Psychology, education and other social sciences (author/ date) date important 2. Chicago Manual of Style (author/ date) origin, footnotes) emphasis on source 3. MLA Handbook for Writers of Research Papers (MLA) - literature & arts (author/ date) authorship important 4. The Harvard system (author/ date) 5. The Vancouver system – used in medical and scientific journal (numeric) • Author Surname followed by Initials.

61. 61 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. • Title of article followed by double quotation. • Title of journal (abbreviated). • Date of Publication followed by double quotation. • Volume Number. • Issue Number in bracket. • Page Number. Example 1. Haas AN, Susin C, Albandar JM, et al. Azithromycin as a adjunctive treatment of aggressive periodontitis: 12-months randomized clinical trial. N Engl J Med. 2008 Aug; 35(8):696-704. Vancouver Style does not use the full journal name, only the commonly- used abbreviation: “New England Journal of Medicine” is cited as “N Engl J Med” RESEARCH ARTICLES STRUCTURING: IMRAD What Is IMRAD? I=Introduction, what question or problem was studied M = Methods, how was the problem studied R = Results, what are the findings A = and D = Discussion, what do these findings mean

62. 62 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Organization of a scientific paper  The most common is the IMRAD If a number of methods were used to achieve directly related results M + R = Experimental section  The results are so complex that they need to be immediately discussed: R + D = Results and Discussion section IMRAD (Introduction, Methods, Research [and] Discussion) • is a mnemonic for a common format used for academic ['scientific'] research papers. While used primarily in the hard sciences, like physics and biology, it is also widely used in the social and behavioral sciences. The IMRAD format is also known as the APA format, as the American Psychological Association uses the IMRAD headings in its APA style sheet. IMRAD is simply a more 'defined' version of the "IBC" [Introduction, Body, and Conclusion] format used for all academic writing. IMRAD format slowly progressed in the latter half of the 19 th century. Essential Parts of a scientific paper  Title: Describe concisely the core contents of the paper  Contact info  Abstract, keywords : Summarize the major elements of the  Body of paper:  Introduction: : provide context & rationale for the study  Materials : Describe the experimental design so it is reproducible  Methods: Describe the experimental procedures  Results : Summarize the findings without interpretation  Discussion: Interpret the findings of the study  Acknowledgements: Give credit to those who helped

63. 63 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Literature Cited: List all scientific papers, books and websites that you cited Why it is used?  Allows experts to rapidly scan through thousands of journal articles to find relevant material.  Allows readers to quickly find what interests them. The title A good title is defined as the fewest possible words that adequately describe the contents of the paper. The title is extremely important and must be chosen with great care as it will be read by thousands, whereas few will read the entire paper Indexing and abstracting of the paper depends on the accuracy of the title. An improperly titled paper will get lost and will never be read. How to Prepare the Title  Make a list of the most important keywords.  Think of a title that contains these words.  The title could state the conclusion of the paper.  The title never contains abbreviations.  Think, rethink of the title before submitting the paper.  Be very careful of the grammatical errors due to faulty word order.  Avoid the use of the word “using”. ABSTRACT

64. 64 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. An abstract can be defined as a summary of the information in a document. The standard word limit of abstract according to APA is 75 to 120 words. Abstract must be- 1. Accurate: which correctly reflects the purpose & content of manuscript. 2. Self-contained- 3. Conise & specific- to make sentence informative & as possible as brief. 4. Non- evaluative- to report information objectively. INTRODUCTION  It should present the nature, details and scope of the problem investigated.  Review the pertinent literature.  State the method of investigation.  State the principal results of the investigation.  State the principal conclusion suggested by the results.  State the purpose – state the Hypothesis explain the purpose behind the Hypothesis. MATERIAL  The source of subjects studied, number of individuals in each group used, their sex, age, and weight must be clearly stated.  If human subjects are used, the criteria for selection should be described, and consent.  For chemicals used, include exact technical specifications and source or method of preparation.  Avoid the use of trade names of chemicals, generic or chemical names are preferred. METHOD  Describe the research & include all the details on how the research was conducted.

65. 65 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Identify sub –sections i. Participants: it describe no. & demographics of participants. ii. Measures: it explains tests or surveys used for the assessments. iii. Procedure: It gives the details on the way of assessment was conducted. RESULTS  Results section is written in the past tense.  It is the core or heart of the paper.  It needs to be clearly and simply stated since it constitutes the new knowledge contributed to the world. TABLES & FIGURES  Tables are appropriate for large or complicated data sets that would be difficult to explain clearly in text. .  Figures are appropriate for data sets that exhibit trends, patterns, or relationships that are best conveyed visually.  Any table or figure must be sufficiently described by its title and caption or legend, to be understandable without reading the main text of the results section.  Do not include both a table and a figure showing the same information. DISCUSSION  Discuss the results of experiment.  Analyze data & interpret the implications of data with respect to original Hypothesis.  Compare the results of current study to work of previous research that was discussed sin introduction.  Recommend what should be done next in regard to future research.

66. 66 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. REFERENCES  Any papers not cited in the text should not be included.  Reference lists allow readers to investigate the subject in greater depth.  A reference list contains only the books, articles, and web pages etc. that are cited in the text of the document.  While a bibliography includes all sources consulted for background or further reading APPENDICES

67. 67 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 5. CLASSICIAL METHODS OF RESEARCH  Pramana can be considered as one of the ancient method of research in developing research methodology in Ayurveda.  According to Charakacharya, the things of this universe such as SAT (existent) or ASAT (non-existent ) can be investigated by these 4 Pramanas & the same are helpful in Swastharakshana, Roga- pariksha, Rogi- Pariksha, Dravya prakshya, & Chikitsa.they are:- 1. Aaptopadesh Pramana 2. Pratyaksha Pramana 3. Anumana Pramana 4. Yukti Pramana  These 4 Pramanas are very much useful at all steps of research such as planning of research work, executing the plan of research & finding a conclusion.  Research is the search for knowledge, it si nothing but a planned program which is used to solve problems & creates a generally applicable new knowledge.  In Ayurveda, the word Praman is derived from from Prama = valid or correct knowledge i.e. the knowledge of science which is explored by various scientific methods.  The critical scientific approach of Ayurveda is evident from its Pramana Vidnyan. Thus, Pramanas are the scientific methods to acquire valid knowledge.  Among all Pramanas, Aaptodesh gives existing knowledge of science , while pratyakshya & anumana gives knowledge after examination.  Aaptodesha is considered as the primary one, as it forms the first source of information about Ayurveda or any other science. It also forms a firm basis for all theorectical knowledge in all aspects.

68. 68 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 1. AAPROPADESHA PRAMANA  It is base of all pramanas.  The term Aaptopadesha is generally confined only with the individual or personality. Aapta, is not merely an individual but also it includes written documents like Vedas, Samhitas, different manuscripts etc. Now a day various research journals, different scientific websites can be taken or considered as Aapta.  Before any research or proposed study, we follow the step i.e. review of the literature which can be correlated with Aaptopadesh. It helps to avoid repetition of work or research. QUALITIES OF AAPTA  Those who were free from RAJA & TAMA i.e. Manasika Doshas.  They have knowledge of 3 Kalas- i.e. past, present & future. IMPORTANCE  In Roga pariksha.  It becomes a base for pratyakshya & Anumana Pramana.  Nidana, roopa & chikitsa of any disease is known by Aaptopadesha.  Without the knowledge of Aaptopadehsa- pariksha or chikitsa is impossible. 2. PRATYAKSHYA PRAMANA  The knowledge which is perceived by sense organs & mind is called as Pratyakshya & the medium of it is called as Pratyaksha Pramana.  It is the best method of knowledge because it is obtained by direct contact of sense organs with the object.  Achayara Charak in Vimanasthana 7/4 has explained that except Rasa (Taste) all other senses can be used for examination of patients, because they are perceived directly.  Nowadays we can increase the capacity of different sense organs with the help of mechanical aids. E.g. » Eyes can be supported or aatisukshma (minute) particles are not are not see by eyes, so here an obstacles comes for Pratyaksha knowledge .so to overcome this microscope is used & for Avarana

69. 69 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. i.e. due to coverings one can’t get directly knowledge of that structure so to overcome this X-ray, USG scan, MRI, endoscope, like visual aids are used. » Tactile sensation can be supported by instruments like thermometer. IMPORTANCE  It helps in Roga & rogi pariksha .  For Darshana, Sparshana, Prashan Parikshya- it is is the best for the diagnosis & prognosis of disease.  To check the improvement in a patient Pratyaksha is compulsory.  Ashtavidha pariksha, Dashavidha pariksha, Sthanika parikshan need most the support of Pratyaaksha.  It gives reliable information about physical & mental changes in patient. 3. ANUMANA PRAMANA  It is indirect knowledge which is based on reasoning (Tarka), or Inference & the inference is based on prior perception.  Medha or grasping capacity or smruti (memory) can be accessed by anumana. In today’s research also most of the psychological experiments are based on questionnaire & conclusion is drawn by anumana or logical inference.  It can be further classified into 3 i. Sheshavata : It means inference of cause (Karana) from effect (Karya )which is related to past. E.g. the undigested food vomiting can imagine as Adhyashana as its cause. In terms of research this can be co-related with Case control study design & said to be retrospective study. ii. Poorvavata: It means inference of effect (Karya) from cause (Karana) & it is related to future. Eg. Hrullasa in Chardi & jrumbha in Jwara disease. In terms of research this can be correlated with Cohort study design & said to be prospective study. It

70. 70 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. iii. Samanyoatodrushta: This type of anumana is related to present .Eg. inference of Agni by Jarana-shakti , Bala by Vyayama-shakti, etc. in terms of research this can be correlated with Cross Sectional Study. IMPORTANCE  It is highly useful in areas of unavailability of sufficient information. In such case, the physician is required to observe the available links & arrive at a conclusion.  Anumana spans over 3 periods of time- past, present & future.  Charaka elaborates further with discreet examples. This refers to an inference of the present situation based on available clue.  Anumana plays a major role in decoding the etiology of a disease & in diagnosis. 4. YUKTI PRAMANA  It means intellectually planning on the basis of Pratyksha & anumana.  The knowledge which sees the things produced by the combination of multiple causative factors is known as YUKTI.  We can get the knowledge of 3 kalas ad also tri-varga- Dharma, Artha & Kama.  Yukti proves to be important tool of diagnosis & treatment when there is involvement of multiple doshas , presence of confusing symptoms, & availability of few treatments options due to contradiction’s in the disease & constitution of the patient.  Yukti helps physician to take decision based on his medical knowledge, practical experience, intelligence, observation & analytical skill to formulate an effective treatment. e.g. If Dr. knows which drug can be effective for the particular disease or according to formulation action then the treatment becomes easy & effective. IMPORTANCE  It plays an important role in Nidana & Chikitsa .

71. 71 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI.  Kriyakala, Agni, Aushadhi sebvana kala, matra ,etc. are known by yukti pramana.  To confirm, evaluate & treat a disease, physician need to perform clinical examinations of patients where aaptopadesha , pratyaksha & anumana are all very important components. DRAVYA- GUNA- KARMA PARIKSHANA PADDATI  The imbalance is occurred through hyper-condition (Vruddhi), Hypo- condition (Kshya), incorrect condition (Dushti) of body constituents.  This conditions can be examined by the changes in body elements Dravyatah (Quantitatively), Gunataha (Qualitatively) & Functionally (Karmatah). 1. Dravyatah Pariksha – Quantitative examinations:- e.g. – if we want to examine Raktadhatu, then Drayataha examination is to examine the exact quantity of Raktadhatu in body by doing investigations like Hemoglobin estimation or Raktadhatu can be examined directly by inspection etc. 2. Gunataha Pariksha – Qualitative examination e.g.- to examine Rakta guna i.e Ushna, Drava properties of Raktadhatu we can examine body temperature or feeling of hotness or coldness through question and liquidity through bleeding time calculation. 3. Karmatah Pariksha – Functional analysis e.g.- Functionally Raktadhatu can be examined by aliveness, proper nourishment to the body parts or bright , soft texture & color of skin, etc.

72. 72 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 6. COMPARISION BETWEEN METHODS OF RESEARCH IN AYURVEDA प्रतिज्ञा स्थापना हेिु उदारण उपनय तनगमन पञ्चअवयव वाक्य, he 5 ancient steps for establishment of fact i.e. प्रतिज्ञा स्थापना हेिु उदारण उपनय & Nigamana is the methodology adopted by ancient Acharayas to establish any principle or fact through correct validation by various examinations & investigations.  The objectives of investigation is to understand things in their correct form – which is called Pratipattidnyanam.  The पञ्चअवयव वाक्य are 1. प्रतिज्ञा: Proposition/ Hypothesis , Ch.Vi.8/30 It is the statement of problem or what to be proved. e.g. पुरुष is eternal. 2. स्थापना : consolidation Confirmation or establishment of Hypothesis. That means establishment of the same proposition firmly on the basis of Hetu, Drushtanta (instant), upanaya (co-relation) and Nigamana (conclusion). 3. हेिु : logical reason It is the cause of knowledge.  हेिु & दृष्ाांि plays important role for arriving the conclusion.  While giving reason or giving possible cause to explain any fact, means & methods of investigation i.e. Pratakshya,

73. 73 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Anumana, Aptopadesha, Upaman etc all these pramanas help to verify & to validate that reasons. 4. उदारण / दृष्ाांि: example / instance Cha.Vi 8/31, 34 Eg. Instance- as sky. If presents resemblance or image of the things to be proved. Eg. Sky is eternal or fire is hot, etc. Such example or illustrations support the validity of statements. 5. उपनय: co- relation/ Comparison Cha.Vi.8 Co- relation – as sky is uncreated & is eternal so is sky. Comparison or co-relation helps to illustrate the problems and gives logical sequence to previous steps. 6. तनगमन: conclusion Conclusion – self is eternal. Conclusion is drawn from the results of such experiments or observations.

74. 74 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 7. DIFFERENT FIELDS OF RESEARCH IN AYURVEDA Refer samhitas 1. panchamahabhuta & tridosha 2. concepts of rasa, guna, virya, vipaka, prabhav & karma 3.concept of Prakriti- saradi bhava, ojas, srotas, agni, aama & kostha.

75. 75 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 8. LITERARY RESEARCH Definition  The process of discovering meaningful new correlations, patterns and trends by sifting through large amounts of data stored in repositories, using pattern recognition technologies as well as statically and mathematics techniques.  Extraction of implicit, previously unknown and potentially useful information from data.  Exploration & analysis, by automatic or semi-automatic means, of large quantities of data in order to discover meaningful patterns.  Extraction of interesting (non-trivial, implicit, previously unknown and potentially useful) information or patterns from data in large databases. Alternative names:  Knowledge discovery(mining) in databases (KDD),  knowledge extraction,  data/pattern analysis,  data archeology,  data dredging,  information harvesting,  Business intelligence, etc. Data Mining Tasks  Prediction Tasks Use some variables to predict unknown or future values of other variables  Description Tasks  Find human-interpretable patterns that describe the data.

76. 76 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. Common data mining tasks 1. Classification [Predictive Tasks] 2. Clustering [Descriptive Tasks] 3. Association Rule Discovery [Descriptive Tasks] 4. Sequential Pattern Discovery [Descriptive Tasks] 5. Regression [Predictive Tasks] 6. Deviation Detection [Predictive Tasks] 1. Classification It can be used to built up idea of type of patients, diseases, or features of patients or diagnosis. 2. Clustering It is useful to identify different information because it co-relates with other examples so you can see where the similarities and ranges agrees. 3. Association Rule Discovery It is used to make a simple correlation between two or more items, often of the same type of identify patterns. 4. Sequential Pattern Discovery Often used over longer-term data, sequential patterns are a useful method for identifying trends or regular occurrences of similar events. 5. Regression To make quantitative predictions of one variable from the values of another. 6. Deviation Detection The difference between an observed values and expected value of a variable or functions.

77. 77 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 9. PHARMACOPOEIAL STANDARDSS & PARAMETERS AS SET BY AYURVEDIC PHARMACOPOEIA OF INDIA. Introduction  India has Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules of 1945 for drug regulation. Also Dangerous Drug Act, 1930 and Poisons Act 1919 define drug related policies.  These acts and related rules regulate export, manufacture, distribution and sale of drugs and cosmetics.  Considering increase in demand, use and export of drugs from Ayurvedic and other systems included in AYUSH; Government of India has specified the rules and notifications related manufacturing, standardization and other aspects of drug usage.  Ayurvedic, Unani and Homoeopathic Pharmacopoeias published by the Govt. of India have prescribed various standards to be followed for ISM & Homoeopathic drugs.  In 2002 Govt. of India published Good Laboratory Practices (GLP) guidelines to guide the drug analysts in maintaining high scientific and professional standards for ensuring only drugs of the highest quality are produced and marketed. In 2003, government issued notification of Good Manufacturing Practices (GMP) to ensure authentic, contamination free quality raw material, manufacturing process and product with desired quality standards. Guidelines for Quality Control Standards for quality control are based on pharmacognostic, physicochemical, phytochemical and biological parameters. General process and parameters employed in present standardization of herbal drugs is described below. 1. Sample collection as per suitable sampling plan

78. 78 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 2. Identification 2.1. Organoleptic characterization 2.2. Specific chemical tests (wherever available) 2.3. Microscopic analysis 2.4. Powder microscopy 2.5. TLC comparison with authentic reference standard 3. Physico-chemical Analysis 3.1. Moisture content 3.2. Volatile / fixed oil determination 3.3. Ash value (total, sulphated, acid insoluble, ash etc.) 3.4. PH of 5 % w/v suspension 3.5. Extractive values (with various solvents like alcohol, water etc.) 3.6. Identity tests (like T.L.C., HPLC etc) 4. Phytochemical analysis 4.1. Quantification of bioactive/marker compounds 4.2. Quantification of characteristic category compounds (like flavonoids, alkaloids, terpenoids, glycosides etc.) 5. Microbiological analysis 5.1. Total viable aerobic count 5.2. Total enterobacteriaceae 5.3. Total fungal count 5.4. Test of specific pathogens (S. aurus, E. coli, P. aeruginosa etc.) 6. Residual analysis 6.1. Foreign matter 6.2. Heavy metals residues (Pb, Cd, Hg, As etc.) 6.3. Pesticide residues (organochloro, organophosperous etc.) 6.4. Mycotoxin residues (Aflatoxins B1, b2, G1, G2, Sterigatocistin, Ochratoxin etc.) 6.5. Radioactive residues 6.6. Solvent residues (volatile organic impurities) 7. Biological activities 7.1. Dose response curve 7.2. Dose and duration 7.3. Limits of desired bioactivity 8. Toxicity or Safety profile 8.1. Acute toxicity (including LD 50 value) 8.2. Sub-acute toxicity

79. 79 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 9. Other documentation 9.1. Rasa (Taste), Veerya (Predominant action), Vipaka (Metabolic action) 9.2. Guna (Properties), Karma (Pharmacological action) 9.3. Authentic/Textual References 9.4. Important Formulations, Dose etc. 9.5. Therapeutic Uses 10. Processing specifications 10.1. Details of manufacturing process 10.2. Bhaavanaa, Mardana, Put`a etc. 10.3. Shelf life, storage Standards for classical dosage forms I Protocol of testing Kvaatha (Decoction) 1. Name of preparation: 2. Reference 3. Organoleptic Characters (Color /Odor etc.) 4. PH 5. Total solids 6. Specific Gravity 7. Test for heavy/toxic metals a. Lead b. Cadmium c. Test for Arsenic d. Mercury 8. Microbial Contamination a. Total viable aerobic count b. Enterobacterciaceae c. Total fungal count 9. Test for specific Pathogens a. E. Coli b. Salmonella Spp. c. S. aureus d. Pseudomonas aeruginosa 10. Test for Aflatoxins a. B1 b. B2 c. G1 d. G2 11. TLC/HPTLC- with marker (wherever possible) 12. Pesticide residue a. Organochlorine pesticides b. Organophosphorous pesticides c. Pyrethroids 13. Dosage 14. Shelf life

80. 80 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. a. Normal b. Accelerated II Protocol of testing Avaleha (Leha and Paaka) 1. Name of preparation 2. Reference 3. Description: a. Macroscopic b. Microscopic 4. Color 5. Odor 6. Taste 7. Consistency 8. Total sugar 9. Reducing sugar 10. TLC/HPTLC 11. Extractive value a. Hexane voluble b. Alcohol soluble c. Water soluble 12. Fat content 13. Loss on drying at 105C 14. Total solid content 15. PH 16. Specific gravity at 25C 17. Ash value: a. Total ash value b. Acid insoluble ash c. Sulphated ash 18. Assay of main ingredients 19. Crude fibre content (in case of Prakshepa Dravya) 20. Test for heavy metals a. Lead b. Cadmium c. Arsenic d. Mercury 21. Microbial contamination. a. Total Bacterial count b. Total fungal count c. Enterobacterciaceae d. Salmonella Spp. 22. Ayurvedic specification

81. 81 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. a. Supakvam b. Tantumatatvam c. Apsumajati d. Karatvam Pidite mudra e. Gandha Varn`a Rasaodbhavam 23. Therapeutic indications 24. Dose 25. Shelf life a. Normal b. Accelerated III Protocol of testing Taila / Ghrita 1. Name of preparation 2. Reference 3. Description 4. Colour (RYB value) 5. Odour 6. Rancidity 7. Coagulation point 8. Specific gravity (wt. /ml.) at room temperature 9. Refractive index at 25C 10. Viscosity 11. Specific tests a. Saponification value b. Acid value c. Iodine value d. Peroxide value (residue) e. Free Fatty acids f. Qualitative test (For particular oil) g. Total fatty matter 12. Test for mineral oil (ISI method) 13. TLC /HPTLC Profile of unsaponifiable matter a. Assay for main ingredients 14. Therapeutic use 15. Dosage 16. Congealing point (for Ghrita only) 17. Shelf Life study a. Normal b. Accelerated. IV Protocol of testing Guggulu (Guggulu based formulations) 1. Name of preparation:

82. 82 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. 2. Reference 3. Description a. Identification b. Macroscopic c. Microscopic d. Uniformity by weight 4. PH 5. Extractives a. Alcohol soluble extract b. Water extract 6. Loss on drying on 105C 7. TLC 8. Ash value: a. Total ash b. Acid insoluble ash 9. Description: general, including colour, odour, taste etc 5. Odour 6. Rancidity 7. Coagulation point 8. Specific gravity (wt. /ml.) at room temperature 9. Refractive index at 25C 10. Viscosity 11. Specific tests a. Saponification value b. Acid value c. Iodine value d. Peroxide value (residue) e. Free Fatty acids f. Qualitative test (For particular oil) g. Total fatty matter 12. Test for mineral oil (ISI method) 13. TLC /HPTLC Profile of unsaponifiable matter a. Assay for main ingredients 14. Therapeutic use 15. Dosage 16. Congealing point (for Ghrita only) 17. Shelf Life study a. Normal b. Accelerated. 18. Test for Aflatoxins a. B1 b. B2 c. G1 d. G2 19. Pesticide residue

83. 83 |Making Simple & Easy to Research Methodology for Ayurveda MD/MS Dr Robin bhusal, Resident Surgeon @ Dept. of P.G Studies in Shalyatantra, SDMCA UDUPI. a. Organ chlorine pesticides b. Organophosphorus pesticides c. Pyrethroids 20. Therapeutic indications 21. Dose 22. Shelf Life study a. Normal b. Accelerated. V Protocol of testing Bhasma 1. Name of preparation 2. Reference 3. Method of preparation a. Method of S`hodhana (purification) with reference b. Method of Bhasma formation with reference c. Types & No. of Put`a (Incunation) d. Bhavana Dravya Used (Trituration material used) 4. Description (colour & texture) 5. Particle size 6. Loss on drying 7. Acid insoluble ash 8. Water solubility. 9. Organoleptic characters: general, including colour, odour, taste etc. 10. Heavy metal test a. Lead b. Cadmium c. Arsenic d. Mercury 11. Assay (of main ingredients) 12. Namburi Spot Test 13. Ayurvedic specifications a. Lusterless (Nis`hchandrikaa) b. Fineness (fine enough to enter in lines of finger - Rekhaapoorn`atva) c. Floats on water (Vaaritara) d. Smokeless (Nirdhooma) e. Tasteless (Nisvaadu) f. Irreversible (Apunarbhava) 14. Dose 15. Method of administration 16. Toxicity report 17. Shelf Life study a. Normal b. Accelerated. (In the final product Bhasma, metals are the compounds forms which are not toxic.)

Research methodology for ayurveda MD/MS

Research methodology for ayurveda MD/MS

Research methodology for ayurveda MD/MS

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