|Year : 2014 | Volume
| Issue : 1 | Page : 3-4
Development of disease wise protocols in Ayurvedic clinical research
Executive Editor - AYU IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India
|Date of Web Publication||29-Sep-2014|
Executive Editor - AYU IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Nishteswar K. Development of disease wise protocols in Ayurvedic clinical research. AYU 2014;35:3-4
Clinical information recorded in Ayurvedic classics is quite often interpreted as experiential and time tested observations, while some are inclined to label it as evidence-based medical data. Vagbhata furnished an authoritative conclusion that one should not question the authenticity of the subject delineated in the classics, but should be followed like Mantra (chant) without any argument since the subject of medicine furnished in the treatise is result oriented.  Scientists of modern times prefer to subject those findings to scientific scrutiny. Department of AYUSH developed Good Clinical Practices (GCP) Guidelines  for clinical trials in Ayurveda, Siddha, and Unani medicines (GCP-ASU) for conduction of clinical trials which may help to produce scientific validation. GCP is a set of guidelines, which encompasses the design, conduct, termination, audit, analysis, reporting, and documentation of the studies involving human subjects. The guidelines seek to establish two cardinal principles: Protection of rights of human subjects (patients/nonpatient volunteers) and generation of authentic clinical trial data of ASU drugs. A systematic study of ASU should be carried out to discover or verify the clinical, pharmacological (including pharmacodynamics/pharmacokinetics), and adverse effects, with the object of determining their safety as well as efficacy.
Phases of clinical trial for ASU drug/patents or proprietary medicines include - Phase I (human pharmacology), Phase II (therapeutic exploratory trials), Phase III (therapeutic confirmatory trials), and Phase IV (postmarketing trials). Clinical research becomes fruitful with the help of well-structured protocols which clearly state the background, objectives, rationale, design, methodology, and considerations of the study. Care should be taken while drafting inclusion and exclusion criteria of diseases by incorporating the cardinal features of diseases as per authentic descriptions mentioned in Ayurvedic classics.
Diseases which are having high incidence are naturally preferred in clinical research. However, epidemiological data with regards to diseases described in Ayurvedic classics (e.g., incidence of Grahani, Prameha, Raktapitta, Amavata, etc.) is not generated though we have such data for diseases described in modern medicine, e.g., diabetes, arthritis, cancer, etc. Framework for documentation of epidemiological data of diseases described in Ayurveda should be developed to strengthen Ayurvedic clinical research.
Several papers have been published by incorporating certain biochemical indices with Joshlin clinical guidelines for diabetes  and most of the time the assessment from Ayurvedic perspective is not included. An attempt has been made to develop clinical research protocol for traditional health sciences (Ayurveda, Siddha, Unani, Sowa Rigppa, and others) and it is generally observed that the protocols have not included Ayurvedic perspective of assessment comprehensively.  Emphasis should be given on Ayurvedic fundamental principles related to diagnosis, management, and assessment of therapeutic response while drafting protocols. The component of Samprapti (pathogenesis) and its alleviation must be well explained from Ayurvedic perspective which enables to label the clinical research as Ayurvedic clinical research. For example, while planning clinical trials on Madhumeha, one should conduct physical examination of patient's urine to exclude Kaphaja and Pittaja-meha in addition to diagnostic criteria based on symptoms of diabetes mellitus. Protocol should include such investigation for assessing the involved Dosha and a proper analysis of prodromal symptoms such as Dantadi Maladhyata (excessive deposition/accumulation of Malas on teeth and other orifices), Karapadadaha (burning sensation of hands and legs),  etc., should be carried out to categorize the prognosis of the disease. Interaction of three Doshas with ten Dushyas engenders only 20 varieties of Prameha. Similarly, the assessment protocols of Dushyas,  that is, Medas, Rakta, Sukra, Kleda, Vasa, Lasika, Majja, Rasa, Ojas, and Mamsa are necessary which was totally ignored in most of the studies carried out so far on Madhumeha. Examination of Varna (color), Rasa (taste), Sparsha (touch) and Gandha (smell)  of Mutra must be carried out to diagnose subtypes of Prameha, though it appears to be a very crude method of assessment, but yet very important criterion for establishing diagnosis according to guidelines of Ayurvedic classics. Basavraju suggested objective assessment of Prameha prognosis, on the basis of residual content after boiling the urine sample of the patient. 
Sulphonylureas act primarily by stimulating the β-islet cells of the pancreas to produce insulin, while biguanides reduce absorption of carbohydrates from the gut. Gymnema sylvestre R. Br. (Meshasringi), Cinnamomum tamala (Buch.-Ham.) T. Nees. and C.H. Eberm. (Tejpatra), Inula recemosa C.B. Clarke (Pushkaramoola), etc., have been demonstrated to bring about blood glucose homeostasis by increasing serum insulin levels and drugs such as Caesalpinia bonducella (L.) Fleming (Latakaranja), leaves of Mangifera indica L. (Amra), etc., act by reducing carbohydrate absorption.  None of the studies reported the hypoglycemic activity in insulin resistance conditions and also not attempted to explain the drug activity against Dushyas involved in Prameha. Focus should be made on these components of Prameha pathogenesis while explaining mode of drug action.
Similarly in the clinical trials on Amavata, the assessment criteria  of American College of Rheumatology are considered in the protocol without incorporating the diagnostic criteria based on Ayurvedic descriptions. In such studies, exclusion criteria for various forms of arthritis are included (Gouty, Psoriatic, osteoarthritis, etc.) without including diseases described in Ayurveda. Joint condition with symptoms such as Angamarda (body ache), Trishna (thirst), Alasya (laziness), Gaurava (heaviness), Jvara (fever), etc., should be labeled as Amavata only irrespective of modern diagnosis to prove the efficacy of the drug in Amavata as suggested in Ayurvedic literature. Exclusion criteria must include Vatarakta, Sandhivata, Kroshtukashirsha which are interpreted as different varieties of arthritis or musculoskeletal diseases. Assessment of Dosha, Dushyas in every disease must be well defined in the protocol. Clinical research protocol, if excludes Ayurvedic component, will be limited to a mere drug screening enquiry.
| References|| |
|1.||Vagbhatta, Arunadutta, Hemadri, Ashtangahridayam, Uttarasthana, Vajikaranavidhi Adhyaya, 40/81. In: Sastri Paradakara HS, editor. Reprint ed. Varanasi: Chaukhambha Surbharati Prakashan; 2010. p. 954. |
|2.||Anonymous. Good Clinical Practice Guidelines for Clinical Trials of ASU Medicine. New Delhi: CCRAS, Department of AYUSH, Ministry of Health and Family Welfare, Govt. of India; 2013. |
|3.||Joslin Diabetes Centre, Boston: Clinical guideline for adults with Diabetes; c2012 [updated 2012 May 16; cited on 2014 Apr 09]. Available form: https://www.joslin.org/docs/Adult_guidelines_-edits_05_16_2012-update_0213_(2).pdf. |
|4.||Anonymous. Clinical Research Protocols for Traditional Health Sciences, New Delhi: CCRAS, Department of AYUSH, Ministry of Health and Family Welfare, Govt. of India; 2010. |
|5.||Madhavakara, Madhava Nidana, Pramehapramehapidikanidana, 33/5. In: Murthy KR, editor. 7 th ed. Varanasi: Chaukhambha Orientalia; 2005. p. 117. |
|6.||Ibidem. Madhava Nidana, Pramehapramehapidikanidana, 33/4; 116. |
|7.||Agnivesha, Charaka, Dridhabala. Charaka Samhita, Chikitsa Sthana, Prameha Chikitsa Adhyaya, 6/12. In: Acharya JT, editor. Reprint ed. Varanasi: Chaukhambha Orientalia; 2000. p. 446. |
|8.||Nishteswar K. Herbs in Vasavarajeeyam. 1 st ed. Varanasi: Chaukhamba Surbharti Prakashan; 2003. pp. 25. |
|9.||Nishteswar K. Diabetes Ayurvedic Herbal Palliative Therapy. 1 st ed. Varanasi: Chowkhambha Sanskrit Series Office; 2006. p. 61. |
|10.||Nishteswar K. Arthritis and Ayurveda. Reprint ed. Delhi: Chaukhamba Sanskrit Pratishthan; 2004. p. 7-8. |
|11.||Madhavakara, Madhava Nidana, Amavatanidana, 25/6. In: Murthy KR, editor. 7 th ed. Varanasi: Chaukhambha Orientalia; 2005. p. 95. |