Ayur research vision 2020

Ayurveda Research
Vision 2020
Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/
Ayurveda Research Vision 2020 @ DrBRKR GAC, HYD, 26-03-14
“Research is creating new knowledge.” -Neil Armstrong

Is Ayurveda Research is
necessary?
“Research is formalized curiosity. It
is poking and prying with a purpose.
” -Zora Neale Hurston
What for we have to do Research?
1) To conform the past experiences
2) To exclude the selected past not
relevant to the present
3) To include the new concepts /medicines
/ procedures / experiences
4) To include new herbs in to Ayurveda

Problems associated with clinical trials
of Ayurvedic medicines
Ashish K Sharma et.al., Problems associated with clinical trials of Ayurvedic medicines, Rev. bras. farmacogn. vol.20 no.2
Curitiba Apr./May 2010, http://dx.doi.org/10.1590/S0102-695X2010000200023
 Integrated approach of many herbal systems does
not differentiate the disease from the patient.
 Ayurveda proposes different interventions at
different stages of disease in the same patient
providing another difficult to control variable in a
clinical trial.
 Herbal medicines used in traditional systems are used
in the humans without any toxicity studies, their
embryotoxic, foetotoxic, and carcinogenic effects are
likely to remain unrecognized in traditional practice
 With Ayurvedic medicines, it is difficult to plan
double-blind randomized clinical trials. For clinical
evidence of safety and efficacy the placebo-controlled,
double blind randomized trial may be considered as
gold standard,

 "there is no scientific evidence to prove that
Ayurvedic medicine can treat or cure Cancer". -
Cancer Research UK,
 "Most clinical trials of Ayurvedic approaches have
been small, had problems with research designs,
or lacked appropriate control groups, potentially
affecting research results.“- U.S. National
Institutes of Health states
 Ayurvedic drug manufacturers believe that GMP /
GCP are not practical and should not applied to
Ayurvedic drugs, as it would involve a huge
amount of cost.
 http://en.wikipedia.org/wiki/Clinical_trials_on_Ayurvedic_drugs

 Ayurvedic parameters like Tridosha,
Panchamahabhuta, Agni, Guna, Veerya, Vipaka,
Prabhava, Avarana, etc. have to be taken in to
account along with contemporary scientific
parameters in the research of Ayurveda
 Inclusion and exclusion criteria, end points,
markers and methodology should be based on
ASU philosophy
 Clarity and Guidance for compliance on issues like
active ingredients, chemical names, impurity
profile, excipients, etc. also to be provided.
Nagesh Sandu, AYUSH GCP : INDUSTRY PERSPECTIVE, Director Sandu Brothers Pvt Ltd Mumbai

What are the challenges faced during Clinical trials of
Ayurvedic and traditional medicines?
 Formulations: It can be challenging to
know which components are having an
effect and why.
 Interactions: Whenever two or more
medications are used, there is the potential
for them to interact with each other.
 Scientific evidence.: Most clinical trials
are small, had problems with research
designs, lacked appropriate control groups,
or had other issues that affected how
meaningful the results were.

Facts
 "Of the 166 plants investigated, 72 (43%) had at
least one or more human studies and 103 (62%) had
one or more animal studies. These results appear to
contradict
 There are difficulties in estimation of "active"
molecules in body fluids in the pharmacokinetic
studies in phase I of drug development especially in
Ayurvedic formulation.
 Storage conditions can also alter the bioavailability of
herbal medicines, which may lead to loss of activity,
fungal or bacterial contamination

 Avoid the herbs have been reported to be poisonous
in planning of clinical trials
 Ayurvedic HMPs (Herbal Medicinal Products) are
marketed as dietary supplements (In the west)
 Many a times the medicine system advocates other
procedures along with oral therapy which again
may or may not be standardized.
 crude raw herb material has number of variations
as per geographical locations, climatic conditions,
environmental hazards, harvesting methods,
collection protocols, etc
 Thus - a uniform research policy in herbal medicines
is need of the hour.
Ashish K Sharma et.al., Problems associated with clinical trials of Ayurvedic medicines, Rev. bras. farmacogn. vol.20 no.2
Curitiba Apr./May 2010, http://dx.doi.org/10.1590/S0102-695X2010000200023

Guidelines for ASU Drugs
 Ayurveda drugs Manufactured in
accordance with formulae as per the
definition given in clause (a) of
Section 3 of the Drugs and Cosmetics
Act, 1940.
 Indian Ethno-medicines based drugs
not covered under Categories I and II
IV. Medicines based on extracts of
medicinal plants of India

GUIDELINES FOR PRE-CLINICAL SAFETY
EVALUATION FOR AYURVEDA
 SUB-CHRONIC TOXICITY TESTS
 Observations and examinations,
 General signs, body weight and food and
water intake
 Hematological examination
 Renal and hepatic functions tests
 Recovery from toxicity

DATA REQUIRED TO BE SUBMITTED WITH APPLICATION FOR
PERMISSION TO CONDUCT CLINICALTRIALS ON AYURVEDA
 Information on the formulation (s)
 2.1 Composition
 2.2 Dosage from
 2.3 Rational with relevant reference
 2.4 Method of Manufacture
 2.5 Standardization Parameters
 Experimental Pharmacology (as the requirement may be)
 3.1 General pharmacological actions
 3.2 Specific pharmacological actions
 Safety data (as the requirement may be)
 4.1 sub-chronic
 4.2 Genotoxicity if required (as per Schedule Y).
 Investigator brochure, Protocol, Case Report Form, Patient
Information Sheet, Informed consent form (English and
local language)
Footnote: The principle rules were published in the Gazette of India vide notification number F. 28-10/45-H
(I), dated the 21st December, 1945 and subsequently amended vide notification number: - (1) GSR 755 (E) dt. 23.10.2008

OBJECTIVES
 Research on Fundamentals of Ayurveda, its
principles and practices including Literature
Research
 Clinical research: Validation of clinical
efficacy of Classical Ayurvedic Formulations
on priority basis including Ayurvedic
Diagnostics and Preventive Health Care.
 Drug Research and Development based on
Ayurvedic principles and Experimental leads

PRIORITY AREAS
 Fundamental Research
i. Tridosha, Prakriti, Agni, Dhatu, Ojas, Srotas,
Ama, Samprapti & Khad Kriya-Kala etc.
ii. Rasa, Guna, Virya, Vipaka and Prabhava
iii. Literature Research; Survey, collection,
transcription / translation and preparation of
classical literature and text books, Medico-
historical investigations of Ayurveda

Selection of topic
 Drug Research and Development
 i. Standardization and Quality Assurance
 ii. Pharmaceutical Research and Development
 iii. Pharmacology [In-vitro & in-vivo methods]
 iv. Biomarker based Mechanism of action
 v. Ethno-medicinal Research: survey and
documentation of medicinal plants/practices etc.
 vi. Veterinary Ayurveda products

Clinical Research
 Broad Areas
 Development of Methods and modalities for
Ayurvedic Clinical research
 Development of protocols for Clinical Trials
 Epidemiological Research
 Promotive and Preventive Health Care
 R & D on Ayurvedic Diagnostics( including
Prakriti and Nadi Pariksha)
 R & D on Panchakarma and standardization of
its procedures.

Diseases /Areas based on strength of
Ayurveda, National priorities
i. Preventive Cardiology
Atherosclerosis
Hypertension
Dyslipidemia
ii. Gastro intestinal disorders
Hepatic Disorders
Diarrhoeas and Chronic
Enteropathies
iii. Musculo-skeletal disorders
Osteoporosis
Osteoarthritis
Rheumatoid Arthritis
iv. Eye diseases
Diabetic Retinopathy
Computer Vision syndrome
v. Metabolic Syndrome and obesity
vi. Diabetes Mellitus
vii. Skin diseases
viii. Respiratory diseases
ix. Generalized Anxiety Disorder
x. Anaemia
xi. Malaria
xii. BPH, Urolithiasis
xiii. Fistula-in-ano, Para-surgical
procedures
xiv. Neurological disorders and Neuro-
degeneration
xv. Rasayana therapy& Geriatrics
xvi. Reproductive & Child Health
xvii. Quality of life (QOL) in cancer
patients

METHODOLOGY AND APPROACH
 Phase- I: Healthy volunteers or subjects (20-100).
Not required for classical Ayurvedic formulations. This
phase may be conducted on case to case basis,
wherever required.
 Phase- II & III: Subjects (several hundred), direct
phase II &III studies will be conducted.
 Phase- IV: Subjects in select disease conditions
(Several hundred to several thousand for assessing
quality of life). This phase may be conducted on case
to case basis, wherever required.

Statutory, Ethical and Research
guidelines:
 Clinical trials should follow the
prevalent statutory, ethical and
research guidelines like GCP
guidelines prevalent in India and the
collaborating centres and these trials
will be registered with Clinical Trial
Registry of India (CTRI).

Preclinical studies:
 Though the Preclinical studies on the
Ayurvedic classical formulations is not
necessary since they are in use for many
years.
 However, pre-clinical studies will be
conducted on these formulations on case to
case basis.
 Quality control studies and pre clinical
Safety/toxicity studies will be conducted at
CCRAS & PLIM and outsourced through
NABL/GLP compliant laboratories.

Procurement of trial drugs:
 Trial drugs for the projects will be
procured from CCARS peripheral
institutes and reputed GMP compliant
industries.
 IMPCL/PLIM/ any state government
undertaking will also be one of the
sources for trial drugs.

Levels of Evidence

Evidence

Need of new research methodology for Ayurveda
 EBM clinical trial regimens limit the use of
Prakriti, Dosha Anubandha-
Anubandhyatwa, Arambhaka and Anugami
Dosha Vikalpa, Swanidana Prakopa
Awaranajanya Prakopa, Prakriti
SamaSamveta-Vikritishamasamveta,
Amavashthapakvavastha, which leads to
variation of dose, dosage form,
Aushadhikala, Anupana, Sahapana,
Pathyapathya, therapeutics like
Panchakarma procedures to be adopted,
etc.
M. S. Baghel
http://www.ayujournal.org, AYU | Jan-Mar 2011 | Vol 32 | Issue 1

The clinical trials in Ayurveda are needed for–
 Revalidation of facts enumerated in
Ayurvedic classics leading to the
explanation of fundamental principles;
 to find out better treatment modalities for
the existing diseases and for newer
diseases;
 to standardize the treatment procedures
scientifically and
 to establish dose, duration, indication and
side-effect profile of any given drug.
M. S. Baghel
http://www.ayujournal.org, AYU | Jan-Mar 2011 | Vol 32 | Issue 1

CTRI registration
 The Clinical Trials Registry - India (CTRI), an online
system (www.ctri.nic.in) for the registration of
clinical trials being conducted in India, has its
secretariat at the National Institute of Medical
Statistics of the Indian Council of Medical Research in
New Delhi.
 You may reach this site from Gateway of –
www.technoayurveda.com
 The CTRI performs quality assurance on submitted
entries, and has a mechanism for obtaining updated
data and as well as performs de-duplication of
submitted trials.

Ayur research vision 2020

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