The quest for evidence-based Ayurveda: lessons learned
Bhushan Patwardhan*
Interdisciplinary School of Health Sciences, University of Pune, Pune 411 007, India Present address: Symbiosis International University, Pune 412 115, India

Ayurveda offers a unique opportunity to evolve a science of healthy, harmonious and long life. Its holistic approach to health and disease, involving body, mind and spirit, can provide a broader framework to understand research data emerging from reductionist biomedical sciences. This overview of a journey of a basic scientist into evidence-based Ayurveda suggests that a holistic gestalt and reductionist mechanisms are mutually complementary. However, such complementarity needs paradigm-shifting new research approaches. Over the past few decades, the outcome and unique lessons learned through network endeavours have given rise to integrative research programmes employing several trans-disciplines. Judicious applications have emerged: ethnopharmacology, botanical drug development, observational therapeutics, Ayurvedic pharmacoepidemiology, reverse pharmacology, Ayusoft, Ayugenomics, Rasayana, Systems Ayurveda and integrative medicine. Several hits, leads and ready-for-application products and processes have emerged. This article provides an account of the research journey, including some detours, towards the destination of several innovative projects, evidencebased Ayurveda and global acceptance of integrative medicine. Keywords: Ayurveda, biomedicine, evidence-based protocols, holistic approach, reductionist mechanisms. SCIENTIFIC research on Ayurveda has come a long way, especially over the last five decades. The earlier focus on isolating active ingredients from medicinal plants for drug development is now moving more towards scientific understanding of basic physiological concepts and processes outlined in Ayurveda. Pioneering work on chemistry and pharmacology of compounds derived from medicinal plants at premier institutes of CSIR, ICMR and DST under the composite drug research project gave many good leads like curcumin and products such as guglip1. At the outset, it is important to acknowledge pioneering contributions of many scientists and thinkers, including G. N. Sen, Ram Nath Chopra, Madan Mohan Malavia, K. N. Udupa, C. Dwarkanath, D. S. Antarkar, Sharadini Dahanukar, M. S. Valiathan, R. A. Mashelkar, G. V. Satyavati, B. M. Hegde, Ashok Vaidya, Sukh Dev,
*e-mail: 1406

G. P. Talwar, C. K. Atal, B. N. Dhavan, Nitya Anand, S. S. Handa, Ranjit Roy Chaudhury, R. D. Lele, Krishna Kumar, R. H. Singh, Darshan Shankar, Gerry Bodeker, Alex Hankey, Vaidya Bhrihaspatidev Triguna, Vaidya P. S. Warrier and many others. A fresh perspective on the scope of scientific research on the basic concepts of Ayurveda came from a decadal vision document highlighting the importance of Ayurvedic biology2. These views were also articulated at a symposium of the Indian National Science Academy (INSA), New Delhi followed by the 70th Annual Meeting of the Indian Academy of Sciences (IASc) at Varanasi in 2004. INSA and IASc have recognized the significance of India’s traditional knowledge and the need to understand it more fully through modern science. These efforts led to significant funding from the Office of the Principal Scientific Advisor, Government of India, for the national research programme ‘Science Initiatives in Ayurveda’. Still, scientific publications on Ayurveda in international peer reviewed journals have remained dismal3. India certainly needs to generate a sufficient evidence base for Ayurveda with the help of modern science and experimental rigour, in order for it to gain wider global acceptance4. Ayurveda and biomedical sciences share the same spirit of open and sincere scientific enquiry; yet their perspectives on the nature of man and the universe are different. Their basic philosophy, logic, ontology, epistemology and biomedical theories are distinct. Ayurveda is basically pragmatic, systemic and holistic, whereas biomedical sciences are theory-based, structural and reductionist5. Biomedical science uses Aristotelian logic and reductionist scientific methodology to guide its propositions. Cellular and molecular biology governs its medical theories, whereas Ayurveda uses the Indian schemes of logic enshrined in the nyaya and vaishiseka schools, tridosha siddhant and dravya guna shastra to guide its medical theory. These epistemological differences call for due care and use of appropriate research methods when attempting the development of any evidence base. A personalized, multi-factorial approach to healthcare and cure has been the basic strategy of Ayurveda as opposed to the generalized and single target strategy of biomedicine. Ayurveda considers body, mind and spirit along with their relationships with the bio-cultural environment. It is often argued that while Ayurveda receives
CURRENT SCIENCE, VOL. 102, NO. 10, 25 MAY 2012

immunology.13. Traditionally. We planned several experiments to find evidence in support of these traditional claims. we were able to isolate three compounds known as monoene. indicating a typical Rasayana effect. NO. Mumbai and the Cancer Research Institute. decoctions. 1407 Lessons from tradition While working with John Barnabas as a graduate student in biochemistry at the School for Biological Studies. Interestingly. The rich knowledge resources and long experience of Ayurvedic therapeutics can pilot us to both future medicines and affordable healthcare. mainly to prevent pain and infection. fractions emulsified using Tween80 saline produced significant toxicity and 100% mortality at a dose of 25 mg/kg. along with detailed information about them. Bhallataka oil showed significant anti-tumour activities in animal models of sarcoma and adenomas. 25 MAY 2012 . These studies indicate the possibility of synergistic activities and the importance of processing and delivery of drugs. however. I completed my dissertation on antimicrobial activity of Semecarpus anacardium. while significant toxicity was observed at the same dose when the test material was converted into an emulsion12. linctus. At the same time. During this time I learned experimental microbiology besides my first exposure to natural product chemistry and the unique experience of working in a networked environment8. This observation prompted us to study its activity on selected anaerobes responsible for infections in cases involving threat of tetanus or gangrene. formulations and dosage regimens. and was exposed to the basics of pharmaceutical medicine and drug development10. tinctures. These studies taught us to respect traditional knowledge and the importance of selecting the correct experimental models and methodologies. NCL. syrups. Hindustan Antibiotics Ltd and Serum Institute of India. milk. There was statistically significant increase in lifespan in the treatment groups. animal pharmacology. but also provided the necessary facilities. popularly known as Bhallataka. which was lost during the process of purification. therapeutic and untoward effects. These bring distinct advantages to the natural product drug discovery process. anti-inflammatory. the Institute of Science.RESEARCH ACCOUNT acceptance and support from the general public. etc. warm water. Ahmednagar in 1980. pathological and psychological aspects of botanical. where special facilities for working with anaerobes were available. The results classified Ayurvedic pills into three distinct types resembling modern pharmaceutical dosage forms such as enteric-coated and slow-release types of tablet14. We could not identify any anticancer compound in pure form even after four years of intensive effort. I gained a research fellowship to continue for my PhD at the Haffkine Institute. A preliminary experiment noted that different Ayurvedic pills respond selectively and differently for parameters like dissolution and disintegration time. Ayurvedic physicians and hospitals have long histories of drugs used-compositions. For example. This gave me an opportunity to work at different institutions in Pune. creams and lotions. This is called Anupana and calls for use of vehicles like honey. 102. Traditionally the nut shell oil of Bhallataka is supposed to have analgesic. teas. This article reviews a few important lessons and leads resulting from our research on evidence-based Ayurveda over the last three decades. black nut or marking nut. diene and triene bhilawanols. a multi-institutional network project for development of an anticancer drug from S. anacardium was supported by the State Department of Science and Technology involving the Haffkine Institute. as described for the method of preparation. none of these was active. We also showed that traditional use involving peanut oil as a delivery vehicle was safe. which were shown to be responsible for specific anaerobic antibacterial activity against Clostridium spp. wines. We studied animal pharmacology to support traditional claims CURRENT SCIENCE. Mumbai. The crude extracts and nut shell oil had significant anticancer activity. I decided to work on Ayurvedic medicinal plants rather than choosing the more soughtafter options in the field of protein biochemistry and evolutionary biology. Attempts were made to isolate the active principle using preparative HPLC coupled with anticancer activity testing of pure fractions. Ayurveda contains information about how to take a particular drug both to enhance potency and reduce toxicity. Ayurvedic pharmaceutics or Bhaishaja kalpana helped us understand the basis of various process and dosage forms like pills. Ayurveda includes knowledge about physiological. and mechanisms of action for the anti-inflammatory and anti-arthritis properties11. These observations offered unique learning and changed our attitude to traditional knowledgeinspired research. Bhallataka is used as first aid for deep wounds due to thorns or nails. In acute and subacute toxicity studies. 10. anti-microbial and anticancer activity. VOL. and their specific uses for various indications. These records are particularly valuable since effectively these medicines have been tested on people for thousands of years7. the same dose in the same experimental conditions yielded zero mortality in a group that received fractions with peanut oil where signs of anabolic activity were observed. In systematic activity directed fractionation. zoological and mineral sources. due appreciation from the scientific and medical community is not forthcoming6. including the National Chemical Laboratory (NCL). Barnabas not only encouraged me to do so. which was a vibrant multidisciplinary biomedical institute where I learned anaerobic bacteriology9. Bhallataka is considered potentially toxic and needs to be processed and consumed along with suitable oil. toxicology.

biomedical. optimum strength of physique and sense organs. anxiolytic17. Ayurvedabased Rasayanas may offer better and safer immunodrugs that can be used as adjuvants in vaccines and cancer treatment32. Tinospora cordifoloia (Guduchi). and reported immunomodulatory activity for various standardized extracts and formulations prepared from them. During this period my research collaborations with Ashok and Rama Vaidya of Bharatiya Vidya Bhavan’s Swami Prakashananda Ayurveda Research Centre were renewed. and to demonstrate myelo and immuno-protective activity in CURRENT SCIENCE. Serum Institute of India. 1408 . This observation has immense importance in the vaccine industry to obtain more efficient and sustained immunostimulation resulting in increased yield of immune sera and immunobiologicals34. ISAM was merged with ISHS and emerged as a pioneering University School addressing issues of ‘health’ and not limited only to ‘medicine’. dietary regimens. including Withania somnifera (Ashwagandha). In 1993. including M. Our group has successfully completed a DST project to develop a vaccine adjuvant in collaboration with our industry partner. S. We have studied a few selected Rasayana plants.21. Karandikar from K. We also worked on anti-ageing activities of Ayurvedic medicines in topical application forms30. K. and some interesting research projects and publications on hypertension15. and seminars on interdisciplinary research. Mutatkar who recognized the value of establishing the Interdisciplinary School of Health Sciences (ISHS). feeling of youthfulness. excellence of luster. nutrition and dietetics as well as doctoral programmes in health biotechnology. I was invited to write a concept paper and then became the first Chairman of this novel School. Various types of tissue-specific Rasayanas such as medhya. offering Master of Public Health and Master of Science programmes in health sciences. immunomodulation and adjuvants Rasayana tantra is one of the eight specialties of Ayurveda. Vaccine adjuvants Newer vaccines like subunit and DNA vaccines are weakly immunogenic and require adjuvants. collaborating with renowned institutions in India and abroad. Antia. NO. Four Indian patents have been filed in the area of vaccine adjuvant36–38. special health promoting behaviour and drugs. immuno27 and myeloprotectants28. VOL. obesity16. We used cyclophosphamide induced immunosuppression to screen plant-derived drugs for anticancer and cytoprotective potential. In one particular study we reported Ashwagandha as a better and safer drug than Ginseng29. converging modern concepts of public health with ancient systems of health. the University of Pune took a major decision to promote evidence-based research in Ayurveda. immunomodulators22 and natural product drug discovery23. 102. P. freedom from disease. This led to significant contributions to ethnopharmacology. including Banu Coyajee. including Ayurveda and Yoga. Hospital and Research Centre in Mumbai. when properly administered. We used a modified Kendrick test that involved challenge of live Pertussis cells intracerebrally where significant increase in antibody titre. Today. 25 MAY 2012 Rasayana. The University invited the eminent international Ayurveda scholar Subhash Ranade to be Professor in charge. Cancer adjuvants Most cancer chemotherapeutic agents are immunosuppressants and cytotoxic. M. anxiety17. supported by a strong advisory board consisting of eminent scientists from Ayurveda. In a period of three years. the University Grants Commission recognized this School by approving a special grant for faculty positions. B. arthritis18. numerical. Sharadini Dahanukar. inflammation20. S. These studies indicate applications of Rasayanas as potential immunoadjuvants that also offer direct therapeutic benefits resulting in lower morbidity and mortality35. genetics. It concerns rejuvenative recipes. the School made significant progress by organizing national and international workshops on research methodology. In 1994. According to Ayurveda. where I continued to work as professor. ISHS remains one of the leading Schools. N.RESEARCH ACCOUNT Interdisciplinary approach In 1989. natural. Ayurveda and pharmacognosy. Deodhar. Sukhatme was invited by the University of Pune as distinguished professor. Phyllanthus embellica (Amalaki) and Semecarpus anacardium (Bhallataka). This was a forward-looking initiative that led to the establishment of the Interdisciplinary School of Ayurvedic Medicine (ISAM) under the Faculty of Science. I had an opportunity to learn from others. social sciences and humanities disciplines.E. memory.19. jeevaniya and lekhaniaya are mentioned in Ayurveda. Bhide. reduced mortality and improvement in overall health was observed33. Rajnikant Arole and R. intelligence. Rasayana can bring many benefits: longevity.31. 10. Asparagus racemosus (Shatavari). giving me the opportunity to work with him and others. Subsequently. Such evidence base generating studies are important to properly position Ayurveda in the competitive international market. H. V. We also evaluated their potential as antistress25.M. respectability and brilliance. N. adaptogenic26. complexion and voice. especially to inflammation and immunopharmacology. Reviews of the current literature available on Rasayana indicate that immunomodulation is the most studied property/activity24. Thus traditional knowledge systems and ethnopharmacology proved useful in bioprospecting safer and effective medicines and treatments.

Modern medicine uses targetbased single drugs. The Council for Scientific and Industrial Research (CSIR) supported an Ayurveda-based herbal drug development project under the NMITLI programme. double-blind. In immune suppressed animals. including Rauwolfia alkaloids for hypertension.45. the anti-hypertensive alkaloid from Rauwolfia serpentina. Reverse pharmacology Ayurveda knowledge allows drug researchers to start from time-tested and safe botanical material. This product will have significant importance in cancer therapeutics. Traditional medicine-inspired drug discovery and development is therefore considered to be an efficient. and has been patented in India and in the US. which became available as a result of work carried out by CIBA in India in close collaboration with Ayurveda experts. time-tested remedies.RESEARCH ACCOUNT ascitic sarcoma-bearing animals39. One US patent has been filed in the area of cancer adjuvants40. In this process safety remains the most important starting point and efficacy becomes a matter of validation. piperidines as bioavailability enhancers. shatavari and guduchi in experimentally induced tumours and infection mouse models. It has ingredients with analgesic and anti-inflammatory activities similar to NASAIDs and also includes ingredients with immunomodulatory. recent trends indicate use of multi-drug therapy. cancer. and many other steroidal lactones and glycosides as immunomodulators. Immunostasis activity We studied pharmacodynamics of ashwagandha. dynamics and precise doseresponse relationships. guggulsterones as hypolipidemic agents. ICMR and AYUSH institutions together to generate evidence-based Ayurveda. 102. particularly in the area of difficult-to-treat chronic diseases such as diabetes. One such attempt to design a multi-ingredient formulation (Artrex) for the treatment of rheumatoid and osteoarthritis has been successfully completed and the formulation tested in a well-designed. psoralens in vitiligo. degenerative diseases like rheumatoid arthritis49. and it also addresses immunopathological interventions required for long-term management of slow. progressive. The story of Artrex The Ayurvedic formulary gives thousands of such multiingredient preparations and an excellent rationale for such formulations in the Ayurvedic classics. ashwagandha exhibited significant dose-dependent potentiation of cellular and humoral immune response comparable to levamisole and faster recovery of CD4+ T cells percentages compared to control and cyclosporin43. developed using advanced technologies from the West. Thus the formulation as a whole acts as a combination of NSAIDs and DMARDs51. randomized. which have the distinct advantage of known pharmacokinetics. This formulation gives therapeutic benefits in acute conditions of pain and inflammation. baccosides in mental retention. 25 MAY 2012 Golden triangle initiative and NMITLI A major thrust for scientific research on Ayurveda was given by R. CURRENT SCIENCE. anabolic. The best example of bioprospecting using traditional knowledge is reserpine. In the future. diseasemodifying and free-radical scavenging activities. A large number of molecules have come out of the Ayurvedic clinical base. A. The normal drug discovery course of ‘laboratory to clinics’ in this case actually becomes from ‘clinics to laboratories’ – a true ‘reverse pharmacology’ approach. This process of natural product drug discovery was later named ‘reverse pharmacology’ by Ashok Vaidya44. especially to counter untoward effects of chemotherapy without compromising their anticancer activity41. The product was co-developed with BioVed Pharmaceuticals. Mashelkar through his Golden Triangle and New Millennium Indian Technology Leadership Initiative (NMITLI) which brought CSIR. It also gives a wide range of multiingredient combinations from simple mixtures to complex processed dosage forms. Our work has helped establish the pharmaco-epidemiological evidence base through systematic documentation and analysis47. Holarrhena alkaloids in amoebiasis. In this process rationale and science will be key attributes. We carried out activity-related extractions to identify best performing candidate drugs. We studied cytokine modulation in vivo using flow cytometry and showed that a 100 mg/kg dose resulted in a significant Th1 response (IL-2. 1409 . arthritis and the like. picrosides in hepatic protection. Multi-ingredient formulations The Ayurvedic database gives information about botanicals that can best be used as single drugs in natural form or in processed form. modern medicine could well come to be based on such ancient. It is available in the market in few countries52. Eastern. faster and affordable strategy46. curcumines in inflammation and withanolides. placebocontrolled clinical trial. VOL.50. hypertension. NO. 10. where one well-recognized cellular target for immunomodulation is Th1–Th2 balance42. asthma. The study indicated immunostasis activity and suggests its use where Th1–Th2 modulation is required. IFN-g) in comparison to levamisole and cyclopsorin. However. particularly in the treatment of diseases like tuberculosis and HIV/AIDS. We have also addressed various aspects of quality control and regulatory issues relevant to botanical drugs48. In these circumstances Ayurvedic multi-ingredient formulations offer distinct advantages.

CSIR NMITLI arthritis project task and team. seven-arm.RESEARCH ACCOUNT Figure 1. placebo-controlled. and stability of the finished products55–59. multi-centric clinical trial with glucosamine as the positive control. All the formulations prepared for clinical trials were manufactured and labelled generally in accordance with US FDA Guidance to Industry for botanical drugs. Following several rounds of national-level consultation involving Ayurvedic scholars. Botanical drug development The NMITLI project brought together experts. In vitro studies using suitable cell and tissue culture models on these formulations revealed CURRENT SCIENCE. They entered a parallel track of open-label observational studies by selected Vaidyas and animal pharmacology studies for safety and efficacy. botanical identification. 102. Based on preliminary studies. Two formulations which performed statistically better than placebo and glucosamine were then taken up for mechanistic studies54. modern science and modern medicine (Figure 1). The project also developed integrative protocols and appropriate research methodologies for evidence-based Ayurveda and botanical drug development53. diabetes and arthritis. five formulations were selected for a randomized. This led to 1410 two platforms of drug formulations for treatment of osteoarthritis and rheumatoid arthritis. 10. institutions of excellence and industries representing Ayurveda. chemical profile and DNA analysis. NO. Three projects were supported for Ayurveda-based herbal drug development for hepatitis. VOL. 25 MAY 2012 . Most of the required tests were performed during the entire process starting from passport data of raw material. many drugs were short-listed.

Quality control Quality and stability testing at pre-formulation stages is a crucial part of drug development. It remains one of the most ancient medical systems widely practised in the Indian subcontinent and has a sound philosophical. The formulations were found to be safe according to OECD guidelines and were devoid of any significant genotoxicity or mutagenic activity in micronucleus tests. nitric oxide release. The traditional hydro-alcoholic extract did not show any significant effect on pharmacokinetics. making medicine more a science and less an art to practice. Safety and pharmacology studies of these formulations in animals demonstrated moderate analgesic and anti-inflammatory activities in both acute and chronic models.S. These changes were concurrent with significant decline in immunomodulatory activity during the third month of accelerated storage. Sushruta and Vagbhata are the main Ayurvedic classics. the technology-based super-critical extract caused a significant reduction in absorption of metformin. US FDA and GMP guidelines. which describe some of its original and profound concepts. Pitta and Vata. The bioprospecting of botanical materials. detailed symptoms. The drug master file and necessary documentation was maintained for review. extractions. 102. Thus adequate control of temperature and humidity is important for WSE containing formulations. NO.RESEARCH ACCOUNT significant chondroprotection (proteoglycan release. HPLC fingerprint analysis showed significant changes in some peaks during real and accelerated storage. diabetes and arthritis. Therefore. Guduchi may be safe to take along with methotrexate69. Our results indicate the need to include pharmacokinetic herb–drug interaction studies as an integral part of evidence for safety. In such cases drug–herb interactions become important. formulation and use has recently been filed by CSIR64. Kapha. The Ayurveda database of human constitution. Ayurveda classifies the whole human population into three major constitutions. which may have the possibility of concurrent consumption. Ayurveda is uniquely patient-oriented. standardized and uniform treatment. An Indian and PCT Patent describing innovative process. We studied CURRENT SCIENCE. 10. disease. yet very few studies are available in this field. Characteristic constituents of ashwagandha root include withanolides such as withaferin A and withanolide A.68. This study may help in proposing suitable guidance for storage conditions and shelf-life of ashwagandha formulations66. The Brihadatrayee consisting of Charaka. experiential and experimental basis. however. We carried out pharmacokinetic and herb–drug interaction studies on rats fed with standardized traditional hydro-alcoholic extract and technology-based supercritical extract of Cassia auriculata for 12 weeks. The results suggest a significant decline in withaferin A and withanolide A content during real and accelerated conditions. We carried out similar studies of chemical quality control of Ayurvedic botanicals. We also observed incidences of clump formation and moisture sensitivity under real-time and accelerated storage conditions. aggrecan release and hyaluronidase inhibition as markers) in an explant model of OA cartilage damage60–63. hypertension and cancer may incur situations where modern drugs and botanical drugs are likely to be consumed concurrently. formulation development and manufacturing of the products was carefully done following WHO. especially for technology-based extracts70. There was reasonable evidence for synergistic activity in the formulations compared to single drugs. The most contemporary commentary on the Brihadatrayee is that of M. where 1411 Drug–herb interactions Several diseases such as diabetes. records or regulatory needs and has been deposited with CSIR. We modified and validated the HPLC–DAD method for quantitative measurement of withanolides and fingerprint analysis65. It has close similarities with basic principles of traditional Chinese medicine71. Concurrent administration (acute as well as sub-chronic) of Guduchi with metformin showed beneficial pharmacokinetic as well as pharmacodynamic interaction leading to enhanced anti-hyperglycemic and antihyperlipidemic activity. Acute as well as sub-chronic pretreatment with Guduchi does not have significant effect on cyclophosphamide pharmacokinetics. We need several such studies on many commonly used synthetic drugs and botanical extracts. 25 MAY 2012 . Valiathan in his Legacy series72. which may help in understanding stability of extracts and formulations67. Our studies indicate that both these extracts are pharmacologically safe and do not show any significant adverse reactions at the tested doses. Acute as well as sub-chronic pretreatment at therapeutic doses of Guduchi does not have significant effect on methotrexate pharmacokinetics. Guduchi also showed reversal of immune suppression associated with cyclophosphamide. so their possible homologous relation to human genetic structure needs to be studied for validation. Towards personalized medicine: AyuSoft and Ayugenomics Ayurveda aims at holistic management of health and disease. logic of treatment and drug-activity libraries may provide new leads in individualized. VOL. Guduchi extracts for possible interaction patterns with three conventional drugs used in the treatment of cancer. We studied physicochemical stability and biological activity of dried ashwagandha root aqueous extract under 6-month real-time and accelerated storage conditions.

An informatics based decision support system with implications for personalized medicine based on the logic and essence of the Brihadtrayee and Madhava Nidana interpreted in terms of our ambitious project on Ayugenomics was conceived. The AyuSoft database includes more than 5 lakh records. 10. all are seen in human beings’76. This specific prescription may also include supportive therapies. humans are classified into three major groups: Negroid. The relationship of human leucocyte antigen (HLA) genes and RA is well known80. a first paper on the concept was published78. Every time the question of proof of concept was rightly raised. We selected the HLA DRB1 gene because it has multiple alleles – many alternative forms of the gene. dietary recipes. drugs. Classifying humans based on phenotypes offers a challenge to biomedical science with the technology to look for underlying genetic variations among phenotypic datasets82. Information related to diseases. A search engine based on digitized Samhitas was developed as a part of AyuSoft. under specified conditions depending on individual constitution and properties of materials. when experimental errors are included. 102. proteomics and pharmacogenetics. so we used HLA DRB1 types to compare individuals with their Ayurvedic tridosha classification. AyuSoft converts the logic of classical Ayurvedic texts into comprehensive. we proposed the original hypothesis that the concept of Prakriti in Ayurveda has strong genetic connotations. In anthropological terms. Mongoloid and Caucasoid. NO. Pune.RESEARCH ACCOUNT the Ayurvedic physician diagnoses. We have studied genetic polymorphism of CYP2C19 in the Maharashtrian population74. establishing a rationale and preliminary experimental support for the concept of an association between HLA alleles and the Ayurvedic tridosha theory of individual Prakriti types. Differences of colour. DescripCURRENT SCIENCE. It justified further experiments on the Prakriti concept. We have done SNP profiling across the intracellular folate metabolic pathway in healthy Indians73. Kalpana Joshi. fundamental form of information – even graphs of algebraic relations in the physical sciences are only very high correlations between variables. AyuGenomics® In 2000. and the technologies of genomics. Understanding and interpreting the importance of such individual variations in different populations for health and disease is an important basic principle of Ayurveda. I presented the Ayugenomics concept to several scientists and venture capitalists for possible funding. The term Ayugenomics® was coined and proposed by me in 2002. physique. VOL. treats and dispenses medicine to every individual patient. because a correlation is a very general. 25 MAY 2012 AyuSoft AyuSoft is a collaborative project between the Government of India’s Centre for Development of Advanced Computing (C-DAC) and the University of Pune. lifestyle changes and treat1412 . authentic. diet and lifestyle advice so as to regain physiological balance. While the Traditional Knowledge Digital Library (TKDL) helps in protecting intellectual property. At this point. treatment guidelines. it set a valuable precedent. data-mining tool and digitized searchable texts. cdac. intelligent and interactive knowledge repositories with the help of complex analytical tools (http://ayusoft. This important principle can form the basis for a form of personalized medicine which will give maximum therapeutic efficacy and high safety to a particular person with a particular disorder. The term Ayugenomics® was legally protected by registering it as a Trade Mark with the statutory authorities of the Government of India79. and was underlined by Charaka several hundred years ago as ‘Every individual is different from another and hence should be considered as a different entity. The implication of the existence of information in a scientific experiment is that there is some cause worth elucidating. As many variations as there are in the universe. but genetically they are almost the same. Our study showed a correlation between specific HLA alleles and Prakriti type. The data-mining tool enables precise information searches using Boolean operators. including the Brihadtrayee and Madhava Nidana. Ayurveda points to the cause of the ‘information’ found in this experiment as being the more general concept of Prakriti. Ayugenomics was planned as a platform to undertake the challenge of developing new strategies of drug discovery by integrating the ancient science and knowledge of Ayurveda with modern science. symptoms. This facilitates the study of the Samhitas enabling quick reference searches and compilations to be made. The result was ‘AyuSoft’.in). This work led to a landmark publication establishing a genetic basis for the concept of Prakriti81. A pragmatic review highlighted how the practice of Ayurveda is personalized and can form the basis for pharmacogenomics and customized medicine77. This knowledge base is accessible through a Decision Support System (DSS). ment procedures can be searched through complex queries employing any number of combinations of search strings. Arvind Chopra and I decided to test the hypothesis using a cohort of rheumatoid arthritis patients available at the Centre for Rheumatic Diseases. Although this was only a tiny hint at the concept of Prakriti. In 2003. Subsequently. causative factors. behaviour and so on are due to single nucleotide polymorphism or SNPs. the need to harmonize and organize the Ayurveda knowledge base in a retrievable software form arose. We have also studied whether the thymidylate synthase and methylene tetrahydrofolate reductase genes are linked with methotrexate response75. capturing information from nine texts. finally resulting in removal of the disorder.

SNP-based genotyping. 10. and cure disease. Our preliminary studies thus demonstrated a probable genomic basis for metabolic differences attributable to Prakriti. and ISHS at the University of Pune. panchakarma. The maniCURRENT SCIENCE. epidemiology. and many more will come in the near future. forward and backward loops. the Institute of Ayurveda and Integrative Medicine (Foundation for Revitalization of Local Health Tradition (FRLHT)). cell biology. We hypothesized that different Prakritis may possess different drug metabolism rates associated with drug metabolizing enzyme polymorphism. medicines. particularly to Indian. The ‘whole to part’ relation of Ayurveda philosophy is important for better understanding its comprehensive structure. NAT and MCRs. 102. There is a lack of exposure to contemporary advances and to disciplines like public health. immunology and pharmacogenomics. To address these issues we have initiated an ambitious fellow programme ‘Vaidya-scientists’ to create a scholarly group of change agents. dynamic and inclusive. Thus the journey of Ayugenomics from a proof of concept paper published in Journal of Alternative and Complementary Medicine (JACM) in 2005 has now reached a higher level of scientific appreciation with papers appearing in PNAS85 and other high-impact journals86. clinical pharmacology. which is an integrative approach of Ayurveda and genomics for the discovery of predictive markers for preventive and personalized medicine. Etiological processes. entity relationships and activity flow (Figure 2). Chinese. The immense data include almost 300 variables describing the logical flow of concepts of Ayurveda which are presented using the SBGN approach for processes. The holistic approach of Ayurveda management aims to establish health through multifarious treatment modalities. and any disturbances in tissues or organs. who are well versed in the richness of the Ayurveda classics and the details and insights of modern biology89. including counselling. fested parts of matter are microcosm representing Purusha or the living and macrocosm representing Loka or the universe. This ambitious programme involves studies related to gene expression profiling. I was invited to start a project on ‘Genomic variation analysis and gene expression profiling of human dosha prakriti based on principles of Ayurveda’. many if not most Ayurveda students lack a robust functional theoretical foundation in either. thereby observing significant correlations between CYP2C19 genotypes and major classes of Prakriti types83. data validation by DNA sequencing. Samprapti. Vaidya scientists The interface between Ayurveda shastra and biomedical sciences is necessary for a creative dialogue between medical professionals from different systems of medicine. entity relations and their applications to health and disease. amongst others. STR-based genotyping and gene polymorphism in P450. It has been truly heartening to witness the rapid progress in high-quality research on the basic principles of Ayurveda initiated through the modest efforts of our group. Today. The question of a genetic basis for traditional medicine is of interest. including individualized lifestyle and diet helps restore health. diet and surgical procedures. dhatu. and reduces their toxicity. the Centre for Cellular and Molecular Biology. The main aims of Ayurveda are to promote health and longevity. Bangalore. Manipal University. MDR. Effects of dravya as diet or drug also as causative factor depend on properties and activities relative to the context. logical and 1413 .87. whereas those of Kapha Prakriti are slow metabolizers. Our group’s pioneering works have thus had a catalytic influence and several groups in India and abroad have undertaken research projects in areas related to Ayugenomics84.90. Disease processes are initiated by causative factors (hetu). possibly providing a new approach to pharmacogenomics. Appropriate conduct. In 2006. mala and agni. GST. involve six steps (shatkriyakal) which manifest into disease. Processing (samskara) augments health-promoting properties of medicines. The ‘Systems Ayurveda’ graphic notation describes schema of the Ayurveda knowledge base in a logic chart as entity relationships with its notation based on the Systems Biology Graphical Notation (SBGN) concept88. where approaches similar to Prakriti are part of the therapeutics. We performed CYP2C19 genotyping in 132 unrelated healthy subjects of either sex by the polymerase chain reaction-restriction fragment length polymorphism technique.RESEARCH ACCOUNT tions in Ayurveda indicate that individuals with Pitta Prakriti are fast metabolizers. VOL. Bangalore. This project is supported by the Principal Scientific Advisor Office of the Government of India and involves a collaborative partnership between the Indian Institute of Science. They are achieved by attaining homeostasis of dosha. pharmaceutics. We have published the first poster of a proposed series broadly describing the logical flow. CSIR has recently established a new line of research named Ayurgenomics. NO. Several good papers have been published. 25 MAY 2012 Ayurveda and integrative medicine Historically Ayurveda has been progressive. biomedical engineering. avoiding causes. Korean and other scientists. building on great scientific. These results needed to be validated using genome wide association studies on larger and diverse sample size. Systems Ayurveda The foundations and logic of Ayurveda are mainly based on Sankhya and Vaisheshika philosophies. Hyderabad. both can be assessed by similar logic and methods.

RESEARCH ACCOUNT Figure 2. This was a result of over 18 CURRENT SCIENCE. Systems Ayurveda. the Institute of Ayurveda and Integrative Medicine (www. philosophical foundations. Figure 3. 10. 25 MAY 2012 . Evidence-based Ayurveda: rationale of integrative study protocols. was established in 2010. NO. but today it is in need of a renaissance to resuscitate its historic expansion and research orientation. To develop and practice the right 1414 model of integrative medicine for India.

Bhushan. and Ghooi. Patwardhan. 2010. Patki. respect and maintain the respective identities. D. Srotas. Shrotri. materials. 1992. Patwardhan. 3. B. Pharm. 2004. 10. 14. Saraf. M. philosophies. S.scidev.. Such an integrative exercise is extremely complex and a challenging balancing act-like riding a tiger92. Patwardhan. Sci. 301. 10. Bull. biomedicine and other contemporary health sciences91. Efficacy of potassium and magnesium in essential hypertension: a double blind. integrative approach will lie in its ability to recognize. 50. Life. 8.. 2006. Med. Vaidya. D.. 4. J. Basic concepts of Ayurveda such as Prakriti. Bull. Ayurvedic knowledge. 86. Haffkine Inst. 25. P. Ending medical dominance over the developing world. therapeutics and personalized approach should be understood and valued during any preclinical and clinical studies. S. Bull.. Studies on mechanism of action of S. M. involving experts from Ayurveda and biomedicine. Ayurveda. We do hope that whenever questions about the scientific validity of Ayurveda are raised in India or abroad. 5. R. ranging from medicinal plants to personalized therapeutics. diet. modern hospital is led by eminent vaidya Gangadharan. Ayurveda and future drug development. and scientific advances in bioCURRENT SCIENCE. Such integrative approaches will facilitate the present quest for evidencebased Ayurveda for affordable and safe healthcare. Curr.. 3–5. VOL. Conceptual framework for new models of integrative medicine. SciDev Net. Patwardhan. Altern. and Sharma. Appropriate research methodology and research protocols should be carefully designed. B. Gokhale. 169–170. was started. evidence-base and scientific rigor. Rasayana and Shatkriyakal may provide new leads for biomedical research. and spirit is important. where integrative protocols for over 30 diseases have been developed and practised. 130– 132.. B. 1982. 15.. P. Shankar. Bangalore. and David.. 6. Patwardhan.. R. D. While it is important to study the evidence base for Ayurveda. Sci. and Ghooi. dosage forms. Patwardhan. Saraf. 1415 Conclusion Absence of evidence is not evidence of absence. 36–39. B. Patwardhan. B. Br. 1117–1121. These initiatives primarily aim to recognize the importance of conserving and revitalizing the Ayurvedic and traditional knowledge systems using an integrative approach to explore mutual relationships with basic sciences. J.. Patwardhan.. Haffkine Inst. during and after the treatment with the help of modern diagnostics. 10. Complement. and Patwardhan. Patwardhan. A.. 1. 27... Ayurveda and natural products drug discovery. Subsequently. and Vaidya. 10. the Journal of Ayurveda and Integrative Medicine (www. D. 1982. B. Chemical and biological properties of Semecarpus anacardium. The knowledge base of Ayurveda. 11.. Singh. NO. Indian Academy of Sciences. Med. S. The classical approach of Ayurveda should not be compromised for convenience of existing scientific research methods. Intl.jaim. 25 MAY 2012 . but a science of life with a holistic approach to health and personalized medicine. integrative and systems approach of Ayurveda involving body. M. S. V. Dhatus. processes and mechanisms. and Patwardhan. processes. Patwardhan. Kapre.. Toxicity of Semecarpus anacardium extract. A new anaerobic inhibitor of herbal origin. logic.. B. 789– 799. and Hooper. diagnosis. 2009. placebo controlled. Sci. 87. The true success and test of the new. Agni. 1. 9–11. 106. Phadke. as is also the rigour of biomedical reductionist research to understand underlying structures. P. U. S. 12.. D. and David. et al. 1988. G. B. B.. • • • • • • • Lessons learned. available at http://www. Ethnopharmacol. Bodeker. medicine together can help in improving our understanding of health and disease processes. B.html 7. This integrative hospital offers classical Ayurveda treatment along with close monitoring of patients before. Med. B. We have learned many lessons over a period of time. 159–164. Antibacterial properties of S. 2... B.. B. Med. R.. anacardium.. B. Patwardhan. Ayurveda: scientific research and publications. 8. Epistemological differences between Ayurveda and biomedicine should be taken into account when designing evidence-based research protocols. K.. Curr.. N. 1990. M. 1988. 9.. S. Ancient Sci. S. J. 11. B.. R. Francis. 30 June 2010. Ayurveda Integr. Ancient Sci. 1990. Ayurvedic Biology – A Decadal Vision Document. methodologies and strengths of all systems. A new 100-bed. V. 1. years of rigorous work at FRLHT at Bangalore founded by Darshan Shankar and Sam Pitroda. 10.. 102. 97. crossover study. J. N. D. it is equally important to ensure that the epistemological differences between the two systems are taken into account when developing appropriate study protocols (Figure 3). B. and Chorghade.. J.. The B. Indian J. 521–523. J. Ghooi. Ayurveda Integr. Binding of monoene bhilwanol on Clostridium tetani.. Life. Valiathan. Haffkine Inst. 2010. R. 1983.RESEARCH ACCOUNT Box 1. B. anacardium in rheumatoid arthritis. Ghooi. Standardisation of ayurvedic tablets.. which are important for future research on evidence-based Ayurveda (Box 1). 13... Bulakh. M. foundations. 1989.. 10. and Shankar.. M. such data will help gain wider acceptance for Ayurvedic medicines93. B. mind. R. 14. Ayurveda is not just a herbal medicine. This approach draws the best from both the systems without compromising the principles of either.

B. Theories and management of aging: modern and ayurveda perspectives.. B. N. 32. Y. Med. Chopra. V. Ethnopharmacol. 51. R. 34. and Gautam.. Anti-anxiety activity of Celastrus paniculatus.. N. 2009. 26. 2009. Filing Date: 200312-08. Joshi. J. Evidencebased Complement. Chopra. 49. and Patwardhan. P. 23. Agarwal. and Gautam. Gautam... D. Patwardhan. A. H. Process for making biologically active aqueous extracts of plant product... Publication Date: 2006-01-20. Datta. Indian J. Indian Drugs. B.. and Chitre. D. 1994. Indian J.. Patki. 1997. Traditional medicineinspired approaches to drug discovery: can ayurveda show the way forward? Drug Discov. B. S. J. B. B... 17. Vaidya. A randomized controlled exploratory evaluation of standardized ayurvedic formulations in symptomatic osteoarthritis knees: a Government of India NMITLI project. Withasol and methods of use.. 495–502. 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Stability study on Boswellia serrata (hydroalcoholic) extract. 2008. and Patwardhan. U. Vaidya. Proc. Whole genome expression and biochemical correlates of extreme constitutional types defined in Ayurveda. Sahoo... J. and Wagh. 25. A. and Nagaral. Shinde. P. and Mukerji. Y.. J. A. P.. 13–15. 133.. A synergistic herbal composition for treatment of rheumatoid and musculoskeletal disorders. 78.. Ph D thesis. Chennai. Sumantran.... 2008. Med. 92. The relationship between chondroprotective and antiinflammatory effects of Withania somnifera root and glucosamine sulphate on human osteoarthritic cartilage in vitro. A. Orient Longman. 2009. Chromatographia. Indian Drugs 2000. Chopra. Novère. Patil.. Preeti. 70. Altern. 25 MAY 2012 1417 . U. S. 2010. V. Kulkarni.. Chiplunkar. Chrak Samhita.. Patwardhan. 67. Res.. 68. ‘Ayugenomics’ – Trade Mark Number 1127075. B. 81. 2007. G. 2009. S. 6–8. Translation 1995.. Joshi. 571–576.... A. 2011. 2010. Patwardhan. 90. Caukhambha Orientalia. 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