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Clinical Studies of Ayurveda - FRLHT

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					Ayurveda: From Diagnosis to Health
Indicated Causes
Pathogenesis

Diet

Contraindicated Indicated Contraindicated Single Drug No Symptoms Homeostasis

Disease Lifestyle

Symptoms
Affecting factors

Constitution
Systems & organs

Precise Diagnosis

Customized Treatment

Medicines

Formulations Indicated Contraindicated

Relief

Good QoL
Tranquil mind

Health

Panchakarma

Age

Well Being

Season
Strength Metabolic status Tolerance Surroundings Patient

Psychological

Counseling

Other Rx

Non-Drug

Diet

Every individual is different from another & hence should be considered as a different entity. Charaka Samhita

Theme

How Can We Retain Comprehensive Approach of Ayurveda in Trials ?

Clinical Studies of Ayurveda
Girish Tillu
PhD Student, Interdisciplinary School of Health Sciences, University of Pune Ayurvedic Physician (Research), Centre for Rheumatic Diseases, Pune

Inputs and Guidance
 Dr  Dr  Dr  Dr  Dr

 Dr

 Dr

Vilas Nanal Dr Narendra Pendse G G Gangadharan Dr Sreekumar Nair Ashwin Raut Dr Bharadwaj Arvind Chopra Dr Pramod Dhumal Prathap Tharyan Sanjeev Sarmukaddam Bhushan Patwardhan

Presentation Plan
1.

2.
3. 4.

5.
6.

Status and Need Experimental Studies Observational Studies Diagnostic Principles of Ayurveda TM Research Guidelines & Case Studies Challenges and Approaches

Ayurveda: Pyramid of Evidence
Cochrane Review PubMed Meta-Analysis PubMed CT PubMed All Google Scholar Google search 1 2 80 1843 18,200 72,90,000

4 % of Ayuvreda related PubMed publications are trials
Need for Strategic Efforts & Guidelines Especially for Clinical Research

Experimental and Observational Studies

Observational Studies
•Prevention of Diseases (Rasayana, Swasthavritta,…) •Study of Causation, Pathogenesis (health disease) •Study of Risk •Study of Safety

Experimental Studies
•Assessment of Intervention Test hypothesis Estimating the Effect

Discussion with Dr Sreekumar Nair

Experimental Studies

Experimental Designs: Key Factors
of Disease  Participants  Intervention  Outcome  Analysis
 Interrelation between Drug and Host factors  Subgroups predicting response  Safety and host factors
 Definition

Defining a Disease
Symptoms: Nidana Panchaka

RA

Aama Vaata

Key Elements of Disease
1. 2. 3. 4. 5. 6.

7.

Name of Disease Causative Factors Classification Body constituents involved Target end organs involved Management Approaches Outcome & Prognosis

Clinical Research in Ayurveda, A Concept Note by Vd Vilas Nanal

Drug Response: Interaction between Host and Drug specific factors
►

Host Factors: (Participants)
       

►

Dosha, Dhatu Prakriti (Constitution) Desha (Surroundings) Bala (Strength) Kala (time/season) Agni (metabolic status) Vaya (Age) Satva (Psycological
Status)

Drug Properties
 Dravya Prakriti (Properties)  Habitat  Collection period & practices  Processing  Preservation  Dosage  Anupana  Route of administration

Combinations

 Satmya (Tolerance)  Ahara (Diet)
 Disease Status

Defining Intervention
Components of Chikitsa Sootra (Comprehensive Management guidelines)
Shamana 1. 2. 3. 4. Langhana : Diet + Drug Pachana Swedana (Fomentation) Snehapaana Pitta Virechana Shodhana Kapha Vamana

Vata Basti

„Intervention‟ = More than a „Drug‟ + Therapies + Diet + Lifestyle + Advice..

…Even „Avoid the Cause‟ also part of „Intervention‟ !

Compromise for Convenience ?
Ayurveda

Therapeutics

Drugs
Oral administration Are Current Addressing ? Limited success in assessing ‘Effectiveness of Ayurveda’ ? False negative results ? Herbal drugs Convenient dosage forms (Tablets, capsules)

Challenges in Intervention
Sootra (management guidelines)  Sequence of management procedures
Pachana  Shodhana 
 Chikitsa

points of therapeutic procedures  Drug selection (specific to disease)  Success criteria of treatment  Defining „conclusion of trial‟

 End

„Quality of Life‟ as Outcome

“Ultimate outcome of management is alleviation of Difficulty, Pain, achieving normal voice; complexion; strength, proper digestion, sound sleep…… intellectual capacities…”
-- Charaka Samhita, Vimanasthana Chapter 8 / 86

Accepted, validated, sensitive, specific tools needed

„Health‟ as an „End Point‟
Criteria of „Swasthya‟ (health) by Kashyapa Samhita (15)
 Desire for food  Proper digestion  Easy elimination of waste products (3)  Optimum level of Sense organs (5)  Tranquil Mind  Attainment of energy & strength  Complexion  Sound sleep  Easy awakening
Inputs from Dr G G Gangadharan
PHYSICAL DOMAIN Pain and discomfort Energy and fatigue Sleep and rest

PSYCHOLOGICAL Positive feelings Thinking, learning, memory and concentration Self-esteem Body image and appearance Negative feelings

Observational Studies

Observational Studies
Case Reports Case Series

Prescription Analysis

Observational Studies

Clinical Documents

Community Practices

RCTs and Observational Studies
For the five clinical topics and 99 reports evaluated, the average results of the observational studies were remarkably similar to those of the randomized, controlled trials. The results of well-designed observational studies do not systematically overestimate the magnitude of the effects of treatment as compared with those in randomized, controlled trials on the same topic.
John Concato, Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs, N Engl J Med 2000;342:1887-92

Strengths of Observational Studies
“When done correctly, epidemiologic studies of drug effects can be both more conceptually demanding and more powerful than the average RCT, especially in assessing drug safety. RCTs offer one kind of knowledge but prevent us from seeing other properties of a drug. Epidemiologic studies can help elucidate those properties but may introduce new blind spots.

We must do both kinds of research with rigor and with humility.”
Jerry Avorn, In Defense of Pharmacoepidemiology — Embracing the Yin and Yang of Drug Research, N Engl J Med 357;22, 2007

Practice of Ayurveda: Huge Observational Data
    




> 1,00,000 books & manuscripts1 57 authentic books2 > 4500 Diseases3 (subtypes, conditions etc) > 81,000 formulations4 > 4,00,000 Practitioners5 Infinite documents, references, experiential data Living tradition & knowledge in public domain

Need innovative approaches for data management newer designs for evidence generation.
1. Dr J Deopujari 4. TKDL database 2. Drug and cosmetic act 1940. 3. AyuSoft database 5. Planning Commission - 11th Plan

&

Documenting Practices
  

Increasing Demand for Ayurveda Electronic Medical / Ayurvedic Records / HIS Basic Minimum Requirements
1. 2. 3. 4. 5. Process and rationale of diagnosis Details of Intervention (Process and Rationale) Measurement of Outcome (Process and Rationale) End Result of the treatment Discussion (Comments)

Process and Rationale of Diagnosis
•

•
• • • •

Causative factors (history) Symptoms Findings of clinical exam Differential diagnoses  confirmation Dashavidha, Ashtavidha Pareeksha Involved srotas, Dhatu, Mala, Agni …

Details of Intervention
•

•
• • •

Process and Rationale Diagnostic variables like stage of disease (Avastha) considered for Treatment decision, Treatment details, details of endpoints achieved (Laghutva for Upavasa) Treatment flow chart Ahara, Vihara, Aushadh with matra, kaala, anupana etc

Measurement of Outcome
•

•
•

•
• •

Process and Rationale Predefined or later assessed (or passively observed) outcomes Clinical / imaging, biochem etc Periodic assessment respect to duration Result of the treatment Treatment outcome (relief), change in outcomes, safety documentation

Discussion (Comment)
is expected and observed effect? How intervention worked, any ► Confounding factors ► Unexpected (adverse or beneficial effects) observed during treatment course, economincs ► Global assessment and comments by patients
► What

Diagnostic Principles of Ayurveda

Classification of Diseases
• Which host specific variables are decisive in certain condition / disease? • Interrelations • Planning Intervention • Measurement of Outcome

Found „1‟ study on diagnostic aspect of „Apasmara‟ in JCAM

Ayurvedic Classification of Diseases

Different Approaches for Different Subsets

Need for determine ‘best suited research methods’ for Ayurveda
We have to address some challenges
► Is

conventional model of randomized, placebo

controlled, superiority trials suitable for Ayurvedic

studies?
► What

modification we require in conventional

clinical trial designs?
► What

should be statistical designs / theories

appropriate for Ayurveda?

TM Research Guidelines & Case Studies

WHO Guidelines form Research in Traditional Medicine
 Objective?

Evaluation in framework TM / conventional?  Study designs Single-case design Black-box design Ethnographic design Observational design  Evaluation of quality of life

WHO Guidelines form Research in Traditional Medicine
 Pragmatic  Ethics

research issues

Standardize methods

and training  Surveillance systems

 Education

Herbal CONSORT Guidelines
Herbal medicinal product name B. Characteristics of the herbal product C. Dosage regimen and quantitative description D. Qualitative testing E. Placebo/control group F. Practitioner
A.
Herbomineral Formulations
Consideration of Ayurvedic Pharmaceutics Intervention other than Drug …

Towards „Ayurveda CONSORT‟
Ayurvedic Management
1. 2. 3. 4. 5. Oral Medicines Ext Applications Yoga Postures Movements

1. 2. 3. 4. 5. 6.

Structure a well-designed clinical question search for sources of best evidence Guidelines for Ethical Research Patient selection (Prakriti, Vikriti) Randomization Blinding A. Recruiting team B. Study participants C. Outcomes Assessors study D. Those analyzing the results

Whole-System Trial
Significant improvement in the Ayurvedic group for •HbA1c (P=.006) •Fasting glucose (P =.001) •Total cholesterol (P =.05) •LDL (P =.04) •Weight (P =.035).

Challenges and Approaches
Research Methods‟  Refining Diagnostic Methods  Validated Disease Specific Outcomes


 „Integrative

Scientific advances in „Outcome‟ measurement


				
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