Clinical Studies with Ayurvedic Formulations-A Practitioner’s Preview
<p>Traditional Indian Medicine (TIM) is a storehouse for developing lead drugs for clinical trials. Although, clinical research in Ayurveda in TIM is a novel concept, it can be said that drugs like Triphala, (mild laxative) Tikatu (bioavailability enhancer) and Dashmoola (anti-inflammatory) are the outcome of trials conducted by ancient scientists. The review shows clinical studies done with formulations used in TIM. The formulations were grouped according to action on human system based on data generated from internet and literary search. Apparently, the studies may be uncontrolled but their importance in conducting or improving previously conducted clinical trials with TIM can’t be ruled out. The knowledge may well-combine with ‘reverse pharmacological’ approach for cost-effective and potential cures from TIM. </p>
Ish Sharma1* and Amritpal Singh2
Introduction
Ayurveda or Traditional Indian Medicine (TIM) is considered to be the oldest- practicing system of medicine. Recently, the herbal drug industry has witnessed explosive growth. CAM systems are in great demand, particularly Traditional Chinese Medicine (TCM) and Traditional Indian Medicine (TIM). Growing popularity of CAM among people, has led to onset of research at molecular and clinical levels [1].
With development of new subjects like medicinal phytochemistry, phytophamacology and phytopharmacotherapy, the importance of clinical research in TIM has become more significant. Analytical study of subjects like Dravyaguna (Medicinal plant Pharmacology) and Kayachikitasa (Internal medicine) is required for enhancing practical utility of TIM [2]. Lack/documentation of clinical trials in TIM has triggered controversies, regarding therapeutic application of formulations used in TIM [3]. Although, formulations of TIM have been used for centuries with success, testing at molecular levels is still a challenge [4]. Pharmacological intervening has opened new age in CAM and TIM research. The concept of reverse pharmacology is rapidly catching up for developing cost- Journal of Natural & Ayurvedic Medicine
effective and potential drug candidates from medicinal plants [5]. In our view, clinical studies in TIM can be divided in to two distinct groups: 1. Controlled studies 2. Uncontrolled studies Recently, favorable clinical studies have appeared for single herb/polyherbal formulations used in TIM for varied aliments. The studies, seems to be appropriate with regard to several parameters like drug selection and standardization, design, patient participation and results. The present review is dedicated to rare clinical studies done on formulations used in TIM. The list of plants or formulations discussed in the review may be incomplete. The leading factor is lack of indexed publication dealing with clinical aspects of TIM. Moreover, the clinical knowledge documented by authors in Ayurvedic journals were done mostly around 1960 when pharmacological and clinical research were not in limelight. Non- availability of full-length papers and English version also contributed to the incomplete list.
Materials and Methods
The key words for the present review were clinical trials, clinical studies, TIM, single herb, polyherbal formulations, and Ayurveda. ABIM (Annotated Bibliography of Indian Medicine), data bank on Indian Medicinal Plants provided by Central Council of Research in Ayurveda and Siddha (CCRAS) and journals related to clinical aspects of Complementary and Alternative Medicine (CAM) were used for searching data, updated until Feb 2007. The references encountered in the search were later consulted. The data generated after systemic literature study was documented according to human anatomy.
Integument System
Sookshma triphala in lipoma, Rudanti (Capparis moonii Hook.f., Capparidaceae) in tubercular lymphadenitis , Patoltriphaladi and Panchatiktaka kwatha in scabies and Arogyavardhini rasa and Gandhaka rasayana in leucoderma [6, 7, 8, 9].
Gastroenterology
Kutaja (Holarrhena antidysenterica Wall., Apocynaceae) in amoebiasis and giardiasis, Mustaka (Cyperus rotundus Linn., Cyperaceae) and Vibhituka (Terminalia belerica Roxb.,Combertaceae) in chronic diarrhea, Triphala and Haritaki (Terminalia chebula Retz., Combertaceae) in constipation and worm infestation Takrarishta and Sunthi (Zingiber officinale) in malabsorption , Tulasi (Ocimum sanctum Linn. Lamiaceae) and Patola (Trichosanthes dioica Linn., Cucurbitaceae) in peptic ulcer [10, 11, 12, 13, 14, 15, 16, 17, 18, 19].
Hepatology
Arogyavardhini Rasa in acute viral hepatitis, hepatic cirrhosis and jaundice, Phalatrikadi kwath in hepatic cirrhosis and Kalmegha (Andrographis paniculata Nees., Acanthaceae) in jaundice [20, 21, 22, 23].
Respiratory System
Haritaki leha , Pippali kshira paka, Sirisa twak kvatha Hardira (Curcuma longa Linn., Zingiberaceae), Snuhi (Euphorbia prostrate Linn. and Euphorbia thymifolia Linn., Euphorbiaceae) and Pippali (Piper longum Linn., Piperaceae) and Pushkaramooladi choorna, in bronchial asthma, trikatu in allergic rhinitis, and Swarna basanta malti rasa , Pithecellobium dulce Benth.,Fabaceae , and Rudanti (Capparis moonii Linn.) and Krishna tulasi (Ocimum sanctum Linn.), in pulmonary tuberculosis [24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35].
Cardiovascular System
Lohasava and Triphala mandoora in anemia [36].
Nervous System
Asthawarga kwatha and Dhanvantara yoga in paralysis, Smrti sagara rasa in amnesia, Ustookhudus churana in migraine, and Ashwagandha (Withania somnifera Dunal., Solanaceae), in epilepsy [37, 38, 39, 40].
Genitourinary System
Guduchi (Tinospora cordifolia (Willd.) Miers ex Hook.F., Menispermaceae) in uremia, and Sveta parpati with Kulatha kwatha in urolithiasis [41, 42].
Musculoskeletal System
Sunthi guggulu, Vatari guggulu and Maharasnadi kwatha in rheumatoid arthritis, Kanchanara gugulu kwatha in rheumatic diseases, Goraksa (Dalbergia lanceolaria L.f., Fabaceae) in frozen shoulder and Bhallataka (Semeecarpus anacardium Linn., Anacardiaceae) in osteoarthritis , Guggul (Commiphora mukul Engl., Burseraceae) and Eranda veej ksheer paka in sciatica [43, 44, 45, 46, 47, 48].
Journal of Natural & Ayurvedic Medicine
Endocrine System
Abnraka (mica) and Chandraprabha vati in diabetes mellitus and Arogyavardhini Rasa in hypercholesterolemia/obesity [49, 50, 51].
ENT
Sharpunkha (Tephrosia purpurea Linn., Fabaceae) in adenoids and acute tonsillitis [52].
Eye
Sookshma triphala in chalazion [53].
Reproductive System
Ashokarishta and Musalikhadiradi kwatha in menorrhagia, and Triphala kwath in leucorrhoea [54, 55].
Results and Discussion
A systemic study afforded several single or poly-herbal, and herbo-mineral and purely mineral based formulations used in TIM. Much of the clinical research was related to respiratory and musculoskeletal system. Among polyherbal formulations, guggul-based formulations were cornerstone for treating arthritis and rheumatism. Use of Triphala was highlighted in various clinical conditions. The major drawback of these clinical studies is lack of control. The studies do emphasize clinical utility of formulations used in TIM, which may be the basis of reinitiating clinical trials. We also believe that instead of expanding list of novel formulations, work should be initiated to evaluate potential of already reported formulations to overcome the shortcomings encountered in earlier clinical studies.
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