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RESEARCH METHODOLOGY AND MEDICAL STATISTICS (FOR POST GRADUATE

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 THE
MOHANDAS INDOLOGICAL SERIES
84
n4N

RESEARCH METHODOLOGY AND

MEDICAL STATISTICS
(According to new Syllabus CCIM, New Delhi for Preliminary
(Post-Graduate Course) MD/MS Ayurveda)

By :
Dr. Bargale Sushant Sukumar
M.D., Ayu., M.Sc. Yoga (Ph.D.)
Assistant Professor
Department of Swasthavritta
S.D.M. College of Ayurveda & Hospital, Hassan, Karnataka

Dr. Shashirekha H.K.

M.D., Ph.D. (Ayurveda), M.A. (Sanskrit)
Associate Professor
Department of Samhita Siddhanta
S.D.M. College of Ayurveda & Hospital, Hassan, Karnataka

CHAUKHAMBHA PUBLICATIONS
New Delhi
Research Methodology and Medical Statistics for P.G. Student
ISBN : 978-81-935235-6-878-93- 81608-94-4

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 Acknowledgements

We express our deep sense of gratitude to Padma Bhushan Dr. D. Veerendra

Heggadeji, the honourable President of Sri. Dharmasthala Manjunatheshwara Education
Society, Ujire, Dakshina Kannada.
Sincere thanks to our Honourable Secretary Dr. B. Yashoverma, Sri. Dharmasthala
Manjunatheshwara Education Society, Ujire, Dakshina Kannada for his blessing and
encouragement in all aspects.
We whole heartedly thank to our respected sir Dr. Prasanna N. Rao Principal and
CMO, Sri. Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Hassan.
We are very Grateful to Dr. Suhas Kumar Shetty, Professor in Dept. of Manasa
Roga, and Dr.Girish K.J Professor, Dept of Kaya chikitsa, Sri. Dharmasthala
Manjunatheshwara College of Ayurveda and Hospital, Hassan, for necessary suggestions
and writing foreword to this text
We express profound & immense gratitude to Dr. Upendra Dixit and Dr. Mallika K.J,
for being very co-operative and supportive
We are very Grateful to Dr. Sanjay K.S. Principal of A.L.N. Rao Memorial
Ayurvedic Medical College Koppa, Dist. Chikmagular, Dr. P.B. Aparaj Principal of
SDM trust’s Ayurvedic Medical College and Hospital, Terdal, Dist-Baglkot and
Dr. Abhijeet Joshi, registrar, professor and Head of the department, Tilak Maharstra
Vidhya Peeth Pune.
We are gratifying our sincere thanks to all our inspiring teachers, colleagues and
friends for endless support.
We are very appreciative to our family members Smt. Leelavathi and Shri. Komari
Gowda H. R., Smt. Sumati and Shri. Sukumar Bargale, Smt. Lolakshamma and Shri.
Suresh H.R., Smt. Neeta and Shri Suresh Bargale, Smt. Sujath and Shri. Manohar Smt.
Pavitra and Shri. Ramesh H.K and Satvik S. Bargale.
I seize this opportunity to thank Mr. Jitendra. S for his timely perceptive support in
executing this work.

Dr. Bargale Sushant Sukumar

Dr. Shashirekha. H. K
 Content

Part - A : Research Methodology

1. Introduction to Research Methodology 3-18
2. General Guidelines and Steps in the Research Process 19-54
3. Preparation of research proposals in different disciplines for submission
to funding agencies taking EMR-AYUSH scheme as a model 55-66
4. Scientific writing and publication skills 67-87
5. Classical Methods of Research 88-111
6. Comparison between methods of research in Ayurveda (Pratigya, Hetu,
Udaharana, Upanaya, Niga-man) and contemporary methods in health
sciences 112-116
7. Different fields of Research in Ayurveda 117-141
8. Literary Research 142-154
9. Drug Research (Laboratory-based)-Drug sources : plant, 155-173
animal and mineral
10. Safety aspects 174-178
11. Introduction to latest Trends in Drug Discovery and Drug Development 179-188
12. Clinical Research 189-213
13. Pharmacovigilance for ASU drugs 214-216
14. Introduction to bioinformatics, scope of bioinformatics, role of computers
in biology. Introduction to Data base- Pub med, Medlar and Scopus.
Accession of databases 217-222
15. Intellectual Property Rights-Diffe-rent aspect and steps in patenting. Information on
Traditional Know-ledge Digital Library (TKDL) 232-240
Part-B Medical Statstics
1. Definition of Statistic : Concepts, Relevance and General Applications of
Biostatistics in Ayurveda 243-251
2. Collection, Classification, Presenta-tion, Analysis and Interpretation
of Data (Definition, Utility and Methods) 252-286
3. Scales of Measurements 287-291
 Content v

4. Measures of Central Tendency Mean, Median and Mode 292-309

5. Vriability : Types and Measures of Variability/Measures of Dispersion/
Measures of Scattering – Range, Quartile Deviation, Percentile, Mean
Deviation and Standard Deviation 310-319
6. Probability : Definitions, Types and Laws of Probability 320-337
7. Normal Distribution/Nitation-N (ms2) 327-333
8. Fundamentals of testing of hypotheses 334-343
9. Univariate Analysis of Categorical Data 344-346
10. Parametric Tests 347-358
11. Non Parametric Methods 359-369
12. Correlation and Regression Analysis 370-382
13. Sampling and Sample size comput-ation for Ayurvedic research 383-391
14. Vital statistics and Demography 392-397
15. Familiarization with the use of Stati-stical software like SPSS/Graph Pad 398-406
Part-C Pretical
1. Pharmaceutical Chemistry 409-415
2. Awareness of Chromatographic Techniques 416-422
3. Pharmacognosy 423-437
4. Pharmacology and Toxicology 438-441
5. Biochemistry (Clinical) 442-451
6. Clinical Pathology 452-455
7. Imaging Sciences 456-461
8. Clinical Protocol Development 462-472
Reference Books 473-474
 Syllabus

Part-A- Research Methodology

1. Introduction to Research
A. Definition of the term research
B. Definition of the term Anusandhan
C. Need of research in the field of Ayurveda
2. General guidelines and steps in the research process
A. Selection of the research problem
B. Literature review: different methods (including computer database) with their
advantages and limitations
C. Defining research problem and formulation of hypothesis
D. Defining general and specific objectives
E. Research design: observational and interventional, descriptive and analytical,
preclinical and clinical, qualitative and quantitative
F. Sample design
G. Collection of the data
H. Analysis of data.
I. Generalization and interpretation, evaluation and assessment of hypothesis.
J. Ethical aspects related to human and animal experimentation.
K. Information about Institutional Ethics Committee (IEC) and Animal Ethics
Committee (AEC) and their functions. Procedure to obtain clearance from
respectivecommittees, including filling up of the consent forms and information
sheets andpublication ethics.
3. Preparation of research proposals in different disciplines for submission to
funding agencies taking EMR-AYUSH scheme as a model.
4. Scientific writing and publication skills.
a. Familiarization with publication guidelines- Journal specific and Consort guidelines.
b. Different types of referencing and bibliography.
c. Thesis/Dissertation: contents and structure
d. Research articles structuring: Introduction, Methods, Results and Discussions
(IMRAD)
5. Classical Methods of Research.
l Concept of Pratyakshadi Pramana Pariksha, their types and application for
Research in
 l Ayurveda.
l Dravya, Guna, Karma-Parikshana Paddhati
l Aushadhi-yog Parikshana Paddhati
l Swastha, Atura Pariksha Paddhati
l Dashvidha Parikshya Bhava
l Tadvidya sambhasha, vadmarga and tantrayukti
6. Comparison between methods of research in Ayurveda (Pratigya, Hetu,
Udaharana, Upanaya, Nigaman) and contemporary methods in health
sciences.
7. Different fields of Research in Ayurveda-Fundamental research on concepts
of Ayurveda
a. Panchamahabhuta and tridosha.
b. Concepts of Rasa, Guna, Virya, Vipak, Prabhav and Karma
c. Concept of Prakriti-Saradi Bhava, Ojas, Srotas, Agni, Aam and Koshtha.
8. Literary Research-
a. Introduction to manuscriptology: Definition and scope. Collection, conse-
rvation, cataloguing.
b. Data mining techniques, searching methods for new literature; search of new
concepts in theavailable literature. Methods for searching internal and external
evidences about authors, conceptsand development of particular body of
knowledge.
9. Drug Research (Laboratory-based)-Basic knowledge of the following:
l Drug sources: plant, animal and mineral. Methods of drug identification.
l Quality control and standardization aspects: Basic knowledge of
Pharmacopoeial standards andparameters as set by Ayurvedic Pharmac-
opoeia of India.
l Information on WHO guidelines for standardization of herbal preparations.
Good ManufacturingPractices (GMP) and Good Laboratory Practices
(GLP).
10. Safety aspects: Protocols for assessing acute, sub-acute and chronic
toxicity studies.Familiarization with AYUSH guidelines (Rule 170),
CDCSO and OECD guidelines.
11. Introduction to latest Trends in Drug Discovery and Drug Development
l Brief information on the traditional drug discovery process
l Brief information on the latest trends in the Drug Discovery process
through employment of rational approach techniques; anti-sense approach,
use of micro and macro-arrays, cell culture based assays, use of concepts
viii Research Methodology and Medical Statistics
Syllabus viii

of systems biology and network physiology

l Brief introduction to the process of Drug development
12. Clinical research : Introduction to Clinical Research Methodology
identifying the priority areas of Ayurveda Basic knowledge of the
following:-
l Observational and Interventional studies
l Descriptive & Analytical studies
l Longitudinal & Cross sectional studies
l Prospective & Retrospectives studies
l Cohort studies
l Randomized Controlled Trials (RCT) & their types
l Single-case design, case control studies, ethnographic studies, black box
design, cross-over design,
l factorial design.
l Errors and bias in research.
l New concepts in clinical trial- Adaptive clinical trials/ Good clinical
practices (GCP)
l Phases of Clinical studies: 0,1,2,3, and 4.
Survey studies - Methodology, types, utility and analysis of Qualitative
Research methods. Concepts of in-depth interview and Focus Group
Discussion.
13. Pharmacovigilance for ASU drugs. Need, scope and aims & objectives.
National Pharmacovigilance Programme for ASU drugs.
14. Introduction to bioinformatics, scope of bioinformatics, role of com-
puters in biology. Introduction to Data base- Pub med, Medlar and
Scopus. Accession of databases.
15. Intellectual Property Rights- Different aspect and steps in patenting.
Information on Traditional Knowledge Digital Library (TKDL).
Part B - Medical Statistics
1. Definition of Statistics: Concepts, relevance and general applications of
Biostatistics inAyurveda.
2. Collection, classification, presentation, analysis and interpretation of data
(Definition,utility and methods)
3. Scales of Measurements - nominal, ordinal, interval and ratio scales.
l Types of variables - Continuous, discrete, dependent and independent
variables.
 l Type of series - Simple, Continuous and Discrete
4. Measures of Central tendency - Mean, Median and Mode.
5. Variability : Types and measures of variability - Range, Quartile deviation,
Percentile,Mean deviation and Standard deviation
6. Probability: Definitions, types and laws of probability,
7. Normal distribution: Concept and Properties, Sampling distribution,
Standard Error,Confidence Interval and its application in interpretation of
results and normal probabilitycurve.
8. Fundamentals of testing of hypotheses:
Null and alternate hypotheses, type I and type 2 errors.
Tests of significance: Parametric and Non-Parametric tests, level of significance
and power of the test, ‘P’ value and its interpretation, statistical significance and
clinical significance.
9. Univariate analysis of categorical data:
Confidence interval of incidence and prevalence, Odds ratio, relative risk and
Risk difference, and their confidence intervals
10. Parametric tests: ‘Z’ test, Student’s ‘t’ test: paired and unpaired, ‘F’ test,
Analysis ofvariance (ANOVA) test, repeated measures analysis of variance
11. Non parametric methods: Chi-square test, Fisher’s exact test, McNemar’s
test, Wilcoxontest, Mann-Whitney U test, Kruskall – Wallis with relevant post
hoc tests (Dunn)
12. Correlation and regression analysis : Concept, properties, computation
and applications of correlation, Simple linear correlation, Karl Pearson’s
correlation co-efficient, Spearman’s rank correlation. Regression- simple and
multiple.
13. Sampling and Sample size computation for Ayurvedic research:
Population and sample. Advantages of sampling, Random (Probability) and non
random (Non-probability) sampling. Merits of random sampling. Random sampling
methods- simple random, stratified, systematic, cluster and multiphase sampling.
Concept, logic and requirement of sample size computation, computation of sample
size for comparing two means, two proportions, estimating mean and proportions.
14. Vital statistics and Demography: computation and applications - Rate,
Ratio, Proportion,
Mortality and fertility rates, Attack rate and hospital-related statistics
15. Familiarization with the use of Statistical software like SPSS/Graph Pad.
Practical
1. Pharmaceutical Chemistry- Familiarization and demonstration of common lab
x Research Methodology and Medical Statistics
Syllabus x

instruments for carrying out analysis as per API

2. Awareness of Chromatographic Techniques
l Thin-layer chromatography (TLC).
l Column chromatography (CC).
l Flash chromatography (FC)
l High-performance thin-layer chromatography (HPTLC)
l High Performance (Pressure) Liquid Chromatography (HPLC)
l Gas Chromatography (GC, GLC)
3. Pharmacognosy- Familiarization and Demonstration of different techniques related
to:-
l Drug administration techniques- oral and parenteral.
l Blood collection by orbital plexuses puncturing.
l Techniques of anesthesia and euthanasia.
l Information about different types of laboratory animals used in experimental
research
l Drug identification as per API including organoleptic evaluation
4. Pharmacology and toxicology
Familiarization and demonstration of techniques related to pharmacology
and toxicology
5. Biochemistry (Clinical)
Familiarization and demonstration of techniques related to basic instruments used in a
clinical biochemistry laboratory-semi and fully automated clinical analyzers, electrolyte
analyzer, ELISA- techniques, nephelometry.
Demonstration of blood sugar estimation, lipid profiles, kidney function test, liver
function test. HbA1, cystatin and microalbumin estimation by nephelometry or other
suitable techniques.
Interpretation of the results obtained in the light of the data on normal values.
6. Clinical Pathology : Familiarization and demonstration of techniques related to basic
and advancedinstruments used in a basic clinicalpathology lab. Auto cell counter, urine
analyzer, ESR, microscopic examination of urine.
7. Imaging Sciences : Familiarization and demonstration of techniques related to the
imaging techniques. Video film demonstration of CT-Scan, MRI-scan and PET-scan.
8. Clinical protocol development
 Part-A
Research Methodology
xii Research Methodology and Medical Statistics

CHAPTER
Introduction to Research Metho-
1 dology

Introducton
Research field has developed during this century from the periphery to the centre of
our social and economic life. Research is undertaken within most professions. More than
a set of skills, it is a way of thinking, examining critically in relation with various aspects
of professional work. It is a habit of questioning about what you do and a systematic
examination of the observed information to find answers with a view to instituting
appropriate changes for a more effective professional service.
The term ‘Research’ consists of two words,
Research = Re + Search
‘Re’ means again and again.
‘Search’ means to find out something.
The following is the process:

henomena Conclusions

‘Re’ is a prefix meaning ‘a gain’, ‘a new’ or ‘over again’.

‘Search’ is a verb meaning ‘to examine closely’ and ‘carefully’, ‘to test’ and ‘try’, or
‘to probe’. Together they form a noun describing a careful, systematic, patient study and
investigation in some field of knowledge undertaken to establish facts or principles.
Therefore, research means to observe the phenomena again and again from different
dimensions. For example there are many theories of learning due to the observation from
different dimensions.
The other terms generally used for ‘research’ are probe, quest, search, enquiry,
investigation, examination, scrutiny, verification, re-establishing, revelation, revalidation,
discovery, exploration, invention.
Ayurveda being an ancient medical science is formulated on the scientific parameters
available in those times. As scientific knowledge on biology, chemistry, physics,
pharmacology, pharmaceutical and other allied subjects started to pour into minds,
xii
 reasoning and explanation started to occupy the driver’s seat. This created the
necessity of research in Ayurveda. Research is the only way available to re-established
old facts through modern metrology. It is not only useful to expand the area of knowledge,
but can also help to develop and advance in new directions. Therefore, it is desirable at
the juncture to define research.
The Ayurveda classic also gives importance to research.
hejer#ÙeeskeâeefjCees efn kegâMeuee YeJeefvle ~ (Ûe.met. 10/5)
Those alone are wise who act after investigation. The research is a process of which
a person observes the phenomena again and again and collects the data and on the basis
of data he draws some conclusions. Research is oriented towards the discovery of
relationship that exists among phenomena of the world in which we live.
Research is an integral part of any academic and non-academic learning, innovations,
and developmental activities. Research is being done in all academic and developmental
institutions but does not meet the expected level of scientific methodology. Moreover, the
researches carried out are not need based and lack in quality. The research should be
directed towards major public health problems.
Medical and health curricula at undergraduate level do not deal with applied basic
scientific aspect of research methodology. There is need to create awareness and impart
training in research to undergraduate, postgraduate and health sciences students and
professionals so as to motivate them for need based quality research in desired areas.
Let’s look at the following questions :
1. What is research, discovery and invention?
2. Why to do research? (Objectives)
3. What are the types of research?
4. How to do research?
5. What is a good research?
An inherent feature of human being is to add something new, to expand the
knowledge by his forethought, serendipity or scientific and systematic acquisition of the
facts and figures. Discovery can be done by various ways. It may be due to unexpected
observations in ongoing work or by chance. The role of the chance in research had been
discussed by many authors.
Characteristics of Research
l It demands clear statement of the problem.
l It establishes the relationship between cause and effect.
xiv Research Methodology and Medical Statistics
CHAPTER
General Guidelines and Steps in
2 the Research Process

A. Selection of the research problem

The first step in starting a research study is to choose a topic for research. The topic
must be related to the area of your interest. You should also consult your colleagues and
seniors for their suggestions regarding a good topic. Attending conferences, seminars and
workshops and reading journals also gives you good ideas regarding topics for new
research. In short keep your eyes and ears wide open while looking for a topic. If the
topic is vast like mental depression identify important areas in that topic and choose to
work on some of these areas. It is very rewarding to concentrate on controversies and/
or gaps in the knowledge in your chosen topic.
It is not worthwhile to spend energy, time and money to reconfirm universally
accepted facts. But a study aimed at challenging any aspect of these accepted facts
should get your top priority. Work on topics that really interest you, studies that are meant
to find answers to questions you are dying to answer, and studies that aim to challenge
current beliefs. One must continuously question everything that we do and ask oneself
whether that is the best way of doing things and why one should not try to find a better
way of doing things. A good researcher is like a child who is constantly curious,
perpetually asking questions and always demanding answers. Given a choice assign
priority to studies which have greater relevance to diseased people. However, for any
reason you are required to work on a topic not of your choice say in the interest of your
institution or department do so with all sincerity and complete dedication.
There are some suggestion for the graduate students and researchers which are
drawn from the different areas of education, social sciences, AYUSH as well as
psychology. There are two factors in the selection of topic external and personal criteria.
External criteria - It involves how the topic is important for the field, availability of
both data and data collection methods and the administration is cooperative or not.
Personal Criteria - It means researcher own interest, time and cost. Criteria for
selection of research problem depends on the following characteristics.
l Personal Inclination - The chief motivation in the way of selecting research problem
 is the personal inclination of the researcher. If a researcher has personal interest in the topic,
he would select that problem for his research work.
l Resources Availability- During the selection, a researcher will see to the resources
available. If these resources like money, time, accommodation and transport are
available to the selection place, then the selection of the problem is easy.
l Relative Importance- The importance and the problem also play a vital role in the
selection of research problem. If the problem is relatively important, then the
researcher tends towards the selection of the problem.
l Researcher Knowledge- The researcher knowledge should play a vital role in the
selection of the research problem. The wisdom and experience of an investigator is
required for well collection of the research data. He can bitterly select a problem.
l Practicality- Practicality is also responsible for the selection. The practical usefulness
of the problem is the main motivation for a researcher to attend it.
l Time-lines of the Problem- some problems take little time for its solution while
others take more time. So, it depends on the time in which we have to complete his
research work.
l Data Availability-If the desired data is available to the researcher, then the problem
would be selected.
l Urgency- Urgency is a pinpoint in the way of the selection of research problem.
Urgent problem must be given priority because the immediate solution can benefit the
people.
l Feasibility- Feasibility is also an important factor for the selection of the research
problem. The researcher qualification, training and experience should match the
problem.
l Area Culture. The culture of the area for which a researcher conducts his research
is also responsible for the selection of research problem.
Characteristic of Research Problem
Any research is a difficult task to achieve and research needs to do a great effort.
Selection of research topic is the first step to success.
1. Research topic must be very clear and easy to understand. It should not distract
people.
2. If a topic is well define is the only way to successful research. The topic should not
create doubt and double impression.

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