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Introduction to Research in

Ayurveda
Dr Sudhikumar K B
Professor
KUHS- School of Fundamental Research in Ayurveda
Post Graduate study
• It’s important because it gives
- Some recognition
- an extension of knowledge
- The future jobs depend upon skills, infrastrural, technological, but the
most important and valuable is the human skill that are enriched
through postgraduate education
Can achieve
• Leadership, cross cultural communication
• Problem solving ability
• Team work can be developed during PG, which highly valued by
employer
• It opens up more career options
• May even spark a career of your own
eg: vrikshayurveda, mrigayurveda
Advantages of PG study
• Develop the skills to give you a career
• Use real world applications to solve problem
• build network that cross cultural borders
• Gain industry relevance for today and tomorrow
• Prepare for future
P G research
• Research journey commences with the selection of a topic
• P G research represent the formal area of a study which is recognized
by a university
• A mechanism by which a graduate learn how to undergo systematic
investigation
• It is only a part of study
• It is not an invention/discovery it is only an apprenticeship in research
Definition of research -Ayurveda
• Anweeksha - defined as re assessment of facts (Naya)

• Anumana – inferential conclusion or interpretation, it is the


correlative analysis of phenomenon with its evidence (Sankhya)

• Anusandhana – cause effect relationship (P V Sharma)


Research
• Derived from French word” recherche” means search
• Systematic collection of data
• Search for knowledge ,gathering data, information and facts for the
advancement of knowledge
• Goal is to produce new knowledge or deepen understanding of a
topic
• It is used to establish or confirm facts
• Observation- generalization of observation to form a hypothesis –
testing the hypothesis
Research can be
• Pose a question, collect data to answer it, and present an answer to
the question
• Investigation or experimentation aimed at the discovery and
interpretation of facts
• Reaffirm the results of previous work
• Is a structured enquiry that utilizes acceptable scientific methodology
to solve problems and create new knowledge
Types of research
Qualitative and Quantitative
( based on collection of data)
Basic research and Applied research
(Based on purpose)
Empirical research and Conceptual research
(Based on outcome)
Ways of research
• Experimental research – direct or indirect observation in the
laboratory or in the field
• Analytical research – a new way of approaching the existing problem
• Scientific method – must be based on empirical and measurable
evidence
• To be qualify as research the process must have to be controlled,
rigorous, systematic, valid and verifiable, empirical and critical
Ayurveda research Paradigm
• Ayurveda accepts the ontological approach of Vaiseshika darsana
Karana padhartha
• Epistemology – explained as the study of criteria
intuition, authoritarian knowledge (Aptopadesa), logical/inferential
knowledge (Anumana) and empirical knowledge ( Pratyaksha),
Ayurveda accepts all these except intuition
• Methodology – research strategy
Ayurveda accepts Nayadarsana which advocates 16 technical terms
(Shodasa padartha) for attaining and verifying knowledge
History of Ayurveda research
• The reference for health and disease begin with Rigveda & Adharaveda
• In Rigveda plants are classified into three groups
Trees (Vriksha) Herbs (Oushadi) Creepers (Virudh)*
Adharvaveda contains description of medicinal plants (293), radical cure
by application of drugs, assessing or observing the properties
More on plant research
Post Vedic period specialization started

*Whitney’s Translation of Adharvaveda


History
• Samhita period 1500 BC – 600 AD
• Earliest codified document on Ayurveda were
Caraka, Susrutha and Vagbhata, classified the disease, described specific
management eg: bhagna even without X-ray or any other technique.
* Ayurveda changed from faith based into reason based practice
• Nighantu and Sangraha grantha 800-1900 AD
• Methodology was
Observation, interpretation, Discussion and documentation
Hortus Malabaricus 1678 A great work of medicinal plant research describing
742 plants
Brief History of Ayurveda Academy
• 1820 – 1826 Study of Indigenous Medicine at Sanskrit colleges Kolkata
• 1826 it was abolished by law
• 1865 Department of Ayurveda started at Maharaja Sanskrit college,
Jaipur, Rajasthan
Milestones
• 1889 First ever college for Ayurveda “ Ayurveda Patasala” at
Thiruvanahapuram in Travancore – Sastrabhushanam
• 1899 Lalit Hari Govt Ayurveda college Philibhit – U P
• 1917 Aryavaidyasala started Ayurveda College at Calicut –
Aryavaidyan
• 1922 Ayurveda as a department of Oriental learning & Theology at
BHU, Varanasi
• 1926 Ayurveda department in Sanskrit college Kochi
• 1933 Tilak Ayurveda Mahavidyalya at Pune
• 1936 Ayurveda College at Kochi
• 1939 Muniyal Ayurveda College Manipal
• 1967 Gujarat Ayurveda University at Jamnagar Gujarath
• 1970 CCIM established
• 1976 National Institute of Ayurveda at Jaipur Rajasthan
Academic research
• 1956 PG education in Jamnagar Gujarat
• 1963 Post Graduate education Started at BHU Varanasi
• !970 Post Graduate education at Jaipur, Thiruvananthapuram
• Later in different colleges
• Total Ayurveda Colleges in India 339*
• PG institutions 109* around 2000 seats
Post independence
• 1952 Government of India established a Central Institute for Research
in Ayurveda at Jamnagar
• 1956 PG Training Centre in Ayurveda was established in this
• 1962 IASR Institute of Ayurveda Studies and Research
• 1967 It became Gujarat Ayurveda University
• Academic research in allover India started on 1970 after the
establishment of CCIM
• 1976 National Institute at Jaipur
CCRAS
• 33 institutes are under CCRAS all over India
• Advisory council for research in indigenous medicine & Homeopathy 1962
• Established CCRIM&H 1969
• CCRAS (central council for research in Ayurveda & Sidha) 1978
• CCRAS (Central council for research in Ayurvedic sciences) 2011
conducting research in Medicinal plants, Pharmaceutical, Clinical,
Standardization of classical formulations and drug development
• Safety & efficacy of 249 plants, 67 formulations and developed 11 new
formulations*

*CCRAS fifty years of transforming research & development in Ayurveda


Research in reputed Ayurveda companies
• Baidyanath –Established in 1917
Identification of herbs with therapeutic value, formulation of new
products, pharmacological & toxicological studies, clinical trail of new
products
• Himalaya Established in 1930 R&D in 2001
Accuracy, efficacy & safety of each products, discovery of novel drug
delivery system, in vitro mutagenicity
• Dabur Research foundation –Established in 1970
Contract research organization in preclinical drug discovery and
development, first polymerized nanoparticle delivery system,
biomarker for translational research.
School of Fundamental Research in Ayurveda
• Kerala University of Health Sciences took decision to establish a School of
Research in Ayurveda – 2011
• School started functioning at Tripunithura in the building transferred to
KUHS by Government Ayurveda College on 2017
• Vision
To conduct high quality state of research in conformity with international
standards
Mission
Strengthening and deepening the theoretical foundations of Ayurveda
through interdisciplinary approach
Areas of Research & Activities
• Fundamental research (9 tool development projects completed)
• Medicinal plant research
• Pharmaceutical research
• Clinical research (4 multicentral and 5 SFRA projects ongoing)
Activities
1 Research
2 Documentation (PG Dissertations of Kerala)
3 Publication (5 books published)
4 Training
Published books
1 Notes on Qualitative research and tool development in Ayurveda
2 Guidelines for Protocol writing
3 Clinical consensus for research in Ayurveda
4 The Structured database of PG dissertations of Kerala
5 Hand book on Bioinformatics & its application in Ayurveda
Present Scenario of clinical practice
• Clinical decision making is based on clinical training, textual
knowledge and clinical experience

• Hence, individual difference can occur

• Ayurveda is deficient in empirical evidence related to clinical practice


and scientific research
Present Scenario
• The belief that Ayurveda is a perfect science and does not need
research and development did harm to Ayurveda

• Research is not only for the proof of efficacy

• Research is a process for validation

• Nobody question the efficacy of Ayurveda drugs, but it should be


supported with evidence for acceptance.
Importance of research
• Research is the foundation of knowledge that brings new ideas.
Research and developmental activities create and disseminates new
knowledge.

Research promotes innovations and this will motivate better learning


and teaching among faculties and students.
Need of research
• To develop evidence based support on the efficacy.
• To generate data on safety, standardization and quality control of
Ayurveda products and practice.
• To review the classical literature
• To evaluate the effectiveness of various formulations
• To assess the effectiveness of particular treatment procedure.
• To upgrade Ayurveda time to time
Need
• Only the facts established after careful examination, observation,
experimental studies supported by accurate data with proper
statistical analysis can only convince the scientific community.
Ayurveda is getting more and more global acceptance. Such demand
only be fulfilled by appropriate research.
It is important for further safety & standardization.
Research is useful to assess the relative effectiveness of healthcare
programmes.
• Research is not to loose the existing knowledge, but to apply it
Evidence based medicine
• Application of scientific research into healthcare practice

• Right care at right time to right patient

• Clinical experience supported by empirical research

• An approach to optimize decision making by use of evidence from


well conducted research
EBM
• Defined as –it is the conscientious, explicit and judicious use of
available best evidence in making decision about the care of the
patient Dr David Sackett

Aim
to integrate the experience of a clinician, the value and preference of
the patient and the best available scientific information in clinical
management
Steps for EBM
1 Critical questioning – clinically relevant question, study design, level
of evidence
2 Systematic retrieval of best evidence
3 Critical appraisal of evidence
4 Application of result into practice
5 Evaluation of performance
Ayurveda
• Ayurveda is getting Global acceptance
• If to be accepted by the scientific community/policy makers it has to
be changed to evidence based Ayurveda
• The efficacy of its management of chronic diseases is accepted, still it
is considered as an alternative medicine
• If the knowledge of Ayurveda has been stagnant and static it may go
into history
• So it has to be updated to the need of the society
Evidence
• Empirical evidence is information acquired by observation or
experimentation

• Nature of evidence in case of Ayurveda may be different from that of


modern science
• Only the facts established after careful examination, observation
supported by accurate data will be accepted
Ayurveda evidence
• Based on Pramana
Prathyaksha -- direct observation
Anumana --- inferential knowledge
(can be two types 1 Prathyaksha purva- based on observation
2 Yuktyapekshaya- derived from hypothetical argument based on
reasoning)
Aptopadesa --- testimony/authoritarian knowledge
Yukthi --- experimentation (multifactorial)
Character of evidence
• Good evidence is not always that approved by probability statistics
than science based evidence

• Science based evidence is patient oriented while statistical evidence is


based on population oriented
Evidence of Ayurveda
Can be from two sources*
1 Historical and present clinical practice
( Classical text is not an evidence, but documentation of practice)

2 Evidence based on scientific research to support various theories,


medicines and procedures
( Research must be without compromising the fundamentals of Ayurveda)

* Bhushan Patwarthan
Lacking of Ayurveda
• Is deficient in scientific evidence related to clinical practice and
scientific research
• Standard treatment protocol or consensus are not available
• Systematic documentation and reliable data on pharmaco
epidemiology and pharmacovigilance for clinical practice is not
available as open access
• Ayurveda unique concepts and theories remain unexplored
eg Agni
* Research literacy
Best evidence
• Controlled clinical trials are considered as the best evidence

• If RCT is not suitable, rigorous observational studies can be done and


published

• Publication is an important indicator of external evidence


• Hence, every work has to be published
Publish
• Original research with insights

• Review article, case reports, case series

• The content must support with charts, tables and diagram if required

• Content distribution unique and authentic


What next
• Ayurveda must be liberated from emotional, pride based, blind
following practice
• Ayurveda need updating in application process.
• Shall be facilitated by need based development
• Updation is needed in tune with the changes of society
• More conceptual research needed
• The aim of Ayurveda research is not to lose the existing knowledge
but to find new practical ways to apply the available knowledge.
We have to overcome
• Lack of questioning attitude
• Lack of training in research methodology, biostatistics, scientific
writing, research ethics
• Lack of research expertise and infrastructure
• Lack of research literacy
Need of clinical trails
• Clinical trials are the main source of evidence based medicine
• Research in clinical practice is a challenge
• In Ayurveda multiple clinical parameters like prakriti, agni, koshta,
aama- niraama state have to be considered
• Moreover have to consider external factors like ritu, desha
• Trails must be registered in clinical trial registry of India
Clinical trail registration
• What to register
• All trials conducted in India
• Randomized or not, involving human participants,
• Any intervention such as drugs (already in the market or otherwise),
• Surgical procedures, preventive measures, lifestyle modifications,
devices, educational or behavioral treatment, rehabilitation strategies,
• All trials being conducted in the purview of the Department of AYUSH
• Clinical trials undertaken by postgraduate students for their thesis
should be also registered, as it facilitates publication.
Registration …
• When to Register
• The trial should be registered in the CTRI before enrolment of the first
participant
Who to register
• It is the duty of the principal investigator (PI) to register the trial.
• Prime sponsor can register if so agreed in the Memorandum of
Understanding.
• In a multi-centric or multi-sponsored trial, the lead PI or lead sponsor
should register the trial.
How to register
• One should first login to CTRI website: www.ctri.nic.in

• Following which, he/she should register himself in CTRI using


“Username” and “Password” and create his/her profile. Once
registered, he/she can go ahead with registration of the trial.

• New trial is then added using the CTRI registration data set as detailed
using the user friendly registration system.
Purpose of clinical documentation
1 communication between health professionals. It informs the care
provided and the out come
2 Accountability ; demonstrate the clinicians accountability, increases
the responsibility and performance management
3 Legislative requirements
4 Quality improvement
5 As a research data
6 For funding and resource management
Academic research so far
• Total 1824 dissertations from 1971 to 2018*
• In 14 specialties
• Mostly clinical trails around 1484
• RCT 123
• In vitro studies 32
• In vivo studies 96
• Conceptual studies 56

* incomplete
Department wise
• Dissertations from 1971 to 2017
• In 14 specialties
• Agadathantra 98
• Dravyaguna 200
• Kaumarabhrithya 49
• Kayachikitsa 237
• Kriyasareera 51
• Manasaroga 64
• Panchakarma 82
• Prasoothi & Streeroga 105
• Rasasastra & Bhaishajyakalpana 155
• Roganidana 52
• Salakyatantra 89
• Salyatantra 114
• Samhita, sidhantha 63
• Swasthavritha 139
• Mostly clinical trails around 1000
• In vitro studies 32
• In vivo studies 96
• Conceptual studies 56
• Anti microbial studies
• Anti bacterial studies
• Safety & toxicity studies
Observations
• Most thesis are correctly followed Research methodology
• In earlier thesis, design are not correctly mentioned
• RCT studies control group is not gold standard
• Samples are taken without following scientific methods
• Most of the studies are observational
• Repetition of thesis
• Copy pasting
• Inadequate exposure to procedure
• Lack of confidence in establishing hypothesis
• Few genuine researches are conducted
• Too few are published
• Not registered in clinical trial registry
Reasons may be
• Lack of enough fund – students are doing as a part of their study and
the expenses are met by them self
• Time – they are getting not enough time, without much knowledge of
research methodology they have to submit the synopsis
• Lack of knowledge about research – Research methodology &
Biostatistics was knew to them
• Not enough training given before writing the dissertation
Corrective measures can be
• Enough Fund may be given by University/ AYUSH/ Science and
Technology/ UGC
• Time of synopsis submit ion may be extended
• More orientation may be given to students in research methodology
& Biostatistics
• Volume, contents, chapters of dissertation to be known to students
• How to write the dissertation to be learn to students
Next steps
• Systematic documentation and rigorous experimentation is crucial to
move towards evidence based Ayurveda

• Standardization,(raw drugs, process, end products, SOP of various


procedures) quality control, safety & efficacy of drugs and scientific
validation of products are essential to achieve the goal of evidence
based Ayurveda
• Research protocols shall be designed on the basic concepts of
Ayurveda
Conclusion
• Acquire new knowledge through research, effectively transfer the

knowledge through education and translate the knowledge into


practice
THANK YOU
sudhikumarkb@gmail.com

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