ayur research vision 2020
DESCRIPTION
Ayurveda Research Vision 2020 by Ayurmitra Dr. K. Shiva Rama Prasad, at http://www.technoayurveda.com/ Guest lecture at DrBRKR GAC, Hyderabad, Andhra Pradesh, on 26-03-14TRANSCRIPT
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Is Ayurveda Research is necessary?
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
“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 experiences2) To exclude the selected past not
relevant to the present 3) To include the new concepts /medicines
/ procedures / experiences4) To include new herbs in to Ayurveda
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Problems associated with clinical trials of Ayurvedic medicines
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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.
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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?
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
"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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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 Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
DATA REQUIRED TO BE SUBMITTED WITH APPLICATION FOR PERMISSION TO CONDUCT CLINICALTRIALS ON AYURVEDA
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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 � Dyslipidemiaii. 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. Anaemiaxi. Malaria xii. BPH, Urolithiasisxiii. 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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
METHODOLOGY AND APPROACH
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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:
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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:
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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:
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Evidence
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Need of new research methodology for Ayurveda
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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–
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
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.
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Ayurveda Research Vision 2020 @ DrBRKR
GAC, HYD, 26-03-14
Dr. K. Shiva Rama
Prasad, at http://www.technoayurveda.com/