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Background Knowledge of the prevailing infant care practices and their effects is important to inform practice and public programs. Infant massage is a traditional practice in India but remains less studied. This study was conducted to study the prevalence and perceptions of infant massage practices in two states of India. Methods A total of 1497 caretakers of children under 18 months of age were interviewed in a cross-sectional study at immunisation units of medical schools in Maharashtra (MH) and Madhya Pradesh (MP) states and through home visits in villages in MH during March through August 2018. Results Infant massage was a prevalent practice (93.8% [95%CI: 92.4,94.9]) in both study states – 97.9%[95%CI:96.9,98.8] in MH and 85.3%[95%CI: 81.9,88.3] in MP – and the prevalence did not vary between male (94.5%) and female (93.5%) infants (p = 0.44). Massage was mostly initiated in the first week of life (82%); it is widely viewed as a traditional practice. It was common to massage the baby once daily (77%), before bathing (77%), and after feeding (57%). Massage was mostly conducted using oils (97%). In MH, preferred oils were a sesame oil-based proprietary traditional medicine oil (36%) and coconut oil (18%) while olive (29%) and mustard (20%) oils were most popular in MP. Commonly reported application techniques included gentle massage with minimal pressure, pressing (30%) and manually stretching certain joints (60%). Commonly reported perceived benefits of infant massage included increased bone strength, better sleep and growth, while no harm was perceived (95%). Conclusion Infant oil massage is a highly prevalent traditional practice in MH and MP. Clear guidance on the use of massage, choice of oil, and techniques for application is required to optimize benefits and minimize risks of this popular traditional practice.

The COVID-19 pandemic has posed several challenges to the Indian healthcare system. Here, we examine the situation in India considering the moral and ethical imperatives of decision making for public health. Currently, in the absence of proven therapies, empirical evidence is being used for treatment of Covid-19 disease. We find a dual standard of practice. Currently, only modern medicine therapies are used on an empirical basis, however, the same principle is not considered for the use of AYUSH systems. Appropriate use of evidence is required. In the ethics context and in the interest of the larger public good, we suggest the inclusion of simple and safe measures from AYUSH systems in the integrative protocols for prophylaxis and treatment of Covid-19. Keywords: AYUSH systems, Covid-19, pandemic, prophylaxis, evidence, empirical evidence, priority setting, public health decision making, global health emergencies,complementary medicine, integrative healthcare.

Objectives To study the efficacy and safety of Withania somnifera (WS) in the prophylaxis against COVID-19 in high risk health care workers (HCW) in comparison to hydroxychloroquine (HCQ). To evaluate general physical and mental health benefits of Ashwagandha. Methods A 16 week randomized prospective, open label, parallel efficacy, two arm multi-centre study. The primary efficacy measure is ‘failure of prophylaxis’ as confirmed COVID-19 by quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR) at any time during the study period. This study on 400 participants from three centres is designed to establish non-inferiority for WS to HCQ for prophylaxis against COVID-19 at 80% power and significance P

As the search for effective treatment for Covid-19 intensifies, traditional medicine systems are receiving increasing attention from researchers as well as the public. While scientific rigour is non-negotiable, there remain fundamental issues to be addressed when bringing evidence from traditional systems. Here we examine some of these issues pertaining to Ayurveda and the underlying philosophical underpinnings, and suggest potential ways to move forward. We find an ability to emerge from the cage of “biomedicalism” and its foundational reductionism essential for appropriate research in Ayurveda. We caution against pursuing research in Ayurveda by just mimicking modern medicine and highlight the need for appropriate use of modern science tools and methods to understand Ayurveda and explore its potential for healthcare. We emphasise the need and potential for transdisciplinary research in Ayurveda. A balance between evidence-based medicine and evidence-informed healthcare is required.

This paper discusses the reasons for emergence of predatory publications in India, engendered by mandates of higher educational institutions: that require stipulated number of research publications for employment and promotions. Predatory journals have eclipsed the merits of open access publishing, compromised ethical practices, and left the research community groping for benchmarks of research integrity and publication ethics. To fight back the menace of predatory publications, University Grants Commission, India has established “Consortium for Academic Research and Ethics” (UGC-CARE) in 2018 to promote and benchmark research integrity and publication ethics among the Indian academia. The present paper discusses the UGC-CARE initiative, its structure, objectives and specifically, “UGC-CARE Reference List of Quality Journals” (UGC-CARE list) and finally, the challenges it faces.

IntroductionThe government of India has rolled out COVID-19 vaccine program for individuals who are 18 years of age and above and priority is being given to the elderly, and individuals with morbidity. Oxford-AstraZeneca COVID-19 vaccine (COVISHIELD™) is most widely used in India. A large number of Indian people have been consuming various traditional medicines in the hope of better protection against COVID-19 infection. Several studies have reported immunological benefits of Ashwagandha and its potential as vaccine adjuvant. We plan to study co-administration of Ashwagandha with COVISHIELD™ vaccine on safety, immunogenicity and protection.Methods and analysisWe designed a prospective, randomized, double blind, parallel group, placebo controlled, two arm, exploratory study on healthy volunteers receiving the COVISHIELD™ vaccine. In addition to the two dose schedule of COVISHIELD vaccine as per national guidelines, participants will be administered 8gm Ashwagandha or placebo tablets respectively per day. Primary outcome measure is immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titres. Secondary outcome measures are safety, protective immune response and quality of life measures. Adverse event following immunization will be monitored at each time throughout the study. Participants will be tracked on a daily basis with a user friendly mobile phone application. Following power calculation 600 participants will be recruited per arm to demonstrate superiority by a margin of 7% with 80% power. Study duration is 28 weeks with interim analysis at the end of 12 weeks.Ethics and disseminationEthical approval was obtained through the Central and institutional Ethics Committees. Participant recruitment is expected to commence by August 2021. Results will be presented in conferences and published in preprint followed by peer-reviewed medical journals.Registration detailsClinical Trial Registry – India (CTRI) Registration Number: CTRI/2021/06/034496. Date of Registration June 30, 2021.Strengths and limitations of this studyNovel study to demonstrate effect of coadministration of immune adjuvant and COVID-19 vaccine on safety and immunogenicity.Randomised placebo controlled 28 weeks study with 80 percent power to demonstrate role of putative natural immunomodulator to augment the protection and reduce breakthrough infectionsState of art immune assays to measure specific antibodies to SARS-CoV-2 to demonstrate both persistent and late upsurge in immune responseDaily tracking of participants using a study specific designed mobile appAn interim analysis is planned to provide information on early immune response after first dose of vaccineParticipants may be reluctant to donate blood repeatedly for immune assays; compliance with the test drug may be a challenge; asymptomatic infections may be missed; the study is not measuring cellular immune response.

ObjectivesTo compare the co-administration of an Ayurvedic drug AYUSH 64 as an adjunct to standard of care (SOC) and SOC for efficacy and safety in the management of COVID-19.DesignMulticentre, parallel efficacy, randomized, controlled, open label, assessor blind, exploratory trial with a convenience sample. Patients followed to complete 12 weeks of study duration.SettingCOVID-19 dedicated non-intensive care wards at 1 government hospital, 1 medical college teaching hospital and 1 medical university teaching hospitalParticipants140 consenting, eligible, hospitalized adult patients suffering from mild and moderate symptomatic COVID-19 and confirmed by a diagnostic (SARS-CoV-2) RT-PCR assay on nasal and throat swab were randomized to SOC or SOC plus AYUSH 64. To be withdrawn if disease becomes severe.InterventionsTwo tablets of AYUSH 64, 500 mg each, twice daily after meals, and continued till study completion. SOC (symptomatic and supportive) as per national guidelines of India for mild and moderate disease.Main outcome measuresTime period to clinical recovery (CR) from randomization baseline and proportion with CR within 28 days time frame; CR defined in the protocolResults140 patients randomized (70 in each arm); 138 patients with CR qualified for analysis. Both groups were matched at baseline. The mean time to CR from randomization was significantly superior in AYUSH 64 group (95% CI -3.03 to 0.59 days); a higher proportion (69.7%) in the first week (p=0.046, Chi-square). No significant differences observed for COVID-19 related blood assays (such as D-Dimer). AYUSH 64 arm showed significant (pConclusionsAYUSH 64 hastened recovery, reduced hospitalization and improved overall health in mild and moderate COVID-19 when co-administered with SOC under medical supervision. It was safe and well tolerated. Further studies are warranted.Trial registrationThe Clinical Trials Registry India Number CTRI/2020/06/025557FundingCCRAS, Ministry of AYUSH, Government of India

Infant massage is a highly prevalent traditional practice in India and other parts of Asia. Clear guidance on safe and effective uses of infant massage is lacking especially in the contemporary times when the traditional knowledge is on the verge of extinction and preparations may differ from in the past. This paper presents a consensus guidance in the form of a standardized protocol for routine massage of infants in home settings. Furthermore, a feasible method to develop an integrative protocol involving traditional and modern medicine experts is described. A modified e-Delphi method was used to develop the protocol. A group of seventeen experts, including academicians and practitioners from disciplines as modern paediatrics, Ayurveda paediatrics, Physiotherapy and Naturopathy participated in three rounds of a Delphi study to evolve the consensus guidance. The present protocol for massage of infants born beyond 34 weeks of gestation and weighing above 1.8 kg is recommended for use by care givers. This provides guidance on the preparation for infant massage such as when to begin massaging the infant, checking fitness of the infant for massage, the appropriate time, environment, person and substance for infant massage and a detailed description of the procedure for infant massage. Paediatricians, obstetricians and other child care practitioners can use this protocol to guide care givers on how to peform infant massage.

As the COVID-19 pandemic is progressing, the therapeutic gaps in conventional management have highlighted the need for the integration of traditional knowledge systems with modern medicine. Ayurvedic medicines, especially Ashwagandha (Withania somnifera (L.) Dunal, WS), may be beneficial in the management of COVID-19. WS is a widely prescribed Ayurvedic botanical known as an immunomodulatory, antiviral, anti-inflammatory, and adaptogenic agent. The chemical profile and pharmacological activities of WS have been extensively reported. Several clinical studies have reported its safety for use in humans. This review presents a research synthesis of in silico, in vitro, in vivo, and clinical studies on Withania somnifera (L.) Dunal (WS) and discusses its potential for prophylaxis and management of COVID-19. We have collated the data from studies on WS that focused on viral infections (HIV, HSV, H1N1 influenza, etc.) and noncommunicable diseases (hypertension, diabetes, cancer, etc.). The experimental literature indicates that WS has the potential for 1) maintaining immune homeostasis, 2) regulating inflammation, 3) suppressing pro-inflammatory cytokines, 4) organ protection (nervous system, heart, lung, liver, and kidney), and 5) anti-stress, antihypertensive, and antidiabetic activities. Using these trends, the review presents a triangulation of Ayurveda wisdom, pharmacological properties, and COVID-19 pathophysiology ranging from viral entry to end-stage acute respiratory distress syndrome (ARDS). The review proposes WS as a potential therapeutic adjuvant for various stages of COVID-19 management. WS may also have beneficial effects on comorbidities associated with the COVID-19. However, systematic studies are needed to realize the potential of WS for improving clinical outcome of patients with COVID-19.

Brain, an important part of the nervous system and one of the largest organs in the body, comprises of fat as the major component. Essential fatty acids (EFAs) help in maintaining the integrity and function of the brain. EFAs are to be obtained from dietary sources and lack of these can lead to impaired brain performance, diseases, and disorders. Ayurveda (the Indian traditional system of medicine) mentions about majja (marrow/nervous system) that originates from meda dhatu (fatty tissue) and is formed from ahara rasa (essence of food). The quality and quantity of ahara rasa affects majja dhatu which in turn is the determinant of the brain performance. Virrudha ahara (eating incompatible food) leads to vitiation of majjavaha srotas (channels), which is the cause of various neurodegenerative disorders and diseases. Panchamahabhoota (five elements) determines the prakriti (constitution) of an individual that is presented as tridosha (three humurs). Dosha type determines the quality of dhatu and finally the brain pattern and performance. While describing jara (aging), Ayurveda takes in consideration prana (life energy) that governs two other subtle essence ojas (the essence of the seven dhatus or bodily tissues) and tejas (the essence of a very subtle fire or energy). Balance of tridosha and prana, ojas, tejas play an important role in maintenance of health. According to Ayurveda the neurodegenerative processes start in the fourth decade of life, which is aligned to the contemporary biosciences views on brain aging. Ayurveda explains Alzheimer’s disease (AD) Smritibhramsha, Parkinson’s disease (PD) Kampvata, Autism spectrum disorder Unmada, and Attention deficit/hyperactivity disorder (ADHD) Dhee, Dhriti, Smriti, Vibramsha. Mind, body, and soul have to be in perfect synchronization for overall health. Ayurveda provides customized treatment approaches and advocates the use of medicinal plants, which can serve as an important lead for modern day new treatments. Medhyarasayana (Ayurvedic drugs that are used to improve memory and cognitive functions) majorly has mention of Brahmi (BacopamMonnieri), Mandukaparni (Centella asiatica), Shankhapushpi (Convolvulus Pluricaulis), Madhuyashti (Glycyrrhiza glabra), Jyotishmati (Celastrus paniculatus), Ashwagandha (Withania somnifera) and Guduchi (Tinospora cordifolia). Panchakarma, Ahara, Yoga, and Nidra are other important approaches that are described for maintenance of good health and to prevent neurodegenerative diseases and disorders.

Ethnopharmacological relevance Withania somnifera (L.) Dunal (WS) is one of the moststudied Rasayana botanicals used in Ayurveda practice for its immunomodulatory, anti-aging, adaptogenic, and rejuvenating effects. The botanical is being used for various clinical indications, including cancer. Several studies exploring molecular mechanisms of WS suggest its possible role in improving clinical outcomes in cancer management. Therefore, research on WS may offer new insights in rational development of therapeutic adjuvants for cancer. Aim of this review The review aims at providing a detailed analysis of in silico, in vitro, in vivo, and clinical studies related to WS and cancer. It suggests possible role of WS in regulating molecular mechanisms associated with carcinogenesis. The review discusses potential of WS in cancer management in terms of cancer prevention, anti-cancer activity, and enhancing efficacy of cancer therapeutics. Material and methods The present narrative review offers a critical analysis of published literature on WS studies in cancer. The reported studies were analysed in the context of pathophysiology of cancer, commonly referred as ‘cancer hallmarks’. The review attempts to bridge Ayurveda knowledge with biological insights into molecular mechanisms of cancer. Results Critical analysisof the published literature suggests an anti-cancer potential of WS with a key role in cancer prevention. The possible mechanisms for these effects are associated with the modulation of apoptotic, proliferative, and metastatic markers in cancer. WS can attenuate inflammatory responses and enzymes involved in invasion and metastatic progression of cancer.The properties of WS are likely to be mediated through withanolides, which may activate tumor suppressor proteins to restrict proliferation of cancer cells. Withanolides also regulate the genomic instability, and energy metabolism of cancer cells. The reported studies indicate the need for deeper understanding of molecular mechanisms of WS in inhibiting angiogenesis and promoting immunosurveillance. Additionally, WS can augment efficacy and safety of cancer therapeutics. Conclusion The experimentally-supported evidence of immunomodulatory, anti-cancer, adaptogenic, and regenerative attributes of WS suggest its therapeutic adjuvant potential in cancer management. The adjuvant properties of withanolides can modulate multidrug resistance and reverse chemotherapy-induced myelosuppression. These mechanisms need to be further explored in systematically designed translational and clinical studies that will pave the way for integration of WS as a therapeutic adjuvant in cancer management.

Our foe is determined and adaptable, says Bhushan Patwardhan. A list of credible titles is the latest salvo in the fight against shoddy scholarship. Our foe is determined and adaptable, says Bhushan Patwardhan. A list of credible titles is the latest salvo in the fight against shoddy scholarship.

Nisha Amalaki (NA), formulation with Curcuma longa Linn (Turmeric, Haridra, Nisha in Sanskrit; Family: Zingiberaceae) and Phyllanthus emblica Linn (Indian gooseberry, Amlaki in Sanskrit; Family: Phyllanthaceae) which is described for various diseases including diabetes in ayurvedic texts and Nighantus. The aim of the present study was to assess the pharmacokinetic (PK) and pharmacodynamic (PD) interactions of chemically standardized NA and Curcuminoids (CE) with metformin (MET) in normal and diabetic animals. Oral administration of NA (200 mg/kg) and CE (30 mg/kg) was carried out for seven days followed by co-administration of MET till fifteen days. MET plasma PK parameters including Cmax, AUC0-∞, t1/2, CL and Vd were measured on the eighth day. PD parameters including plasma glucose AUC followed by oral glucose tolerance test, high-density lipoproteins (HDL), total cholesterol (TC) and triglycerides (TG) were measured on the fifteenth day. In normal animals, co-administration of NA + MET and CE + MET resulted in significant increase (p

Child under nutrition continues to be a challenge to global development, especially in resource-poor contexts. In the multifaceted attempts to address this challenge, popular traditional practices, although closely linked to infant health, remain neglected and less researched. The World Health Organization’s recent strategy on traditional medicine systems provides overarching guidance in this regard. In this commentary, we attempt to exemplify this. We highlight the importance of traditional child care practices with regard to child nutrition and the need for trans-disciplinary research to explore the potential of these for public health. Infant oil massage appears to be a potentially beneficial practice for child nutrition. Rigorous trans-disciplinary research on traditional infant massage can provide simple solutions to address child under nutrition and nurture human capabilities globally.

To address many challenges faced in successfully bringing a medicine to market, all the stakeholders of the biomedical ecosystem need to collaborate. This ecosystem includes academia, nonprofit and for-profit research institutions, government agencies, the pharmaceutical industry, and disease foundations. Given the complexities and the expense of RD all partners, especially the academic scientist, must work harder to rebuild and regain this confidence.

Typically, a drug is anything that prevents, alleviates, cures, or manages disease with the ultimate goal of reestablishing health. Many times the concept of medicine gets reduced to the use of material pharmaceutical drugs mainly for symptomatic management. Overemphasis of pharmaceutical drugs in clinical practice overlooks concepts of homeostasis and interplay of biological networks. The holistic management of the patient involves dietary modifications, exercise, counseling, therapeutic procedures and behavioral modifications. Emerging research on lifestyle and behavioral interventions suggests several mechanisms those can reduce and replace use of medicines. Ayurveda and yoga suggests holistic management with triad of drugs, diet, and lifestyle. Lifestyle and behavior management holds importance as therapeutic interventions but are more beneficial for risk reduction, disease prevention, and health promotion. Lifestyle research can minimize the use of drugs and can provide safer, affordable, accessible, and optimistic approaches for management and even reversal of noncommunicable diseases. The latest research in psycho-neuro-immunoendocrinology shows meditation can act like drugs and has the potential to modulate several physiological functions. The shift from medication to meditation will be the future of medical science.

Scientific advances over the last 25 years, especially in omics, high throughput screening technologies, combinatorial chemistry, instrumentation and informatics, have opened exciting avenues for the discovery of new drug candidates. Nevertheless, major challenges remain and are constantly evolving. The rate of new discoveries is falling and many drugs approved by regulators are being withdrawn due to toxicity and safety concerns. The drug discovery process is facing severe bottleneck and innovation deficit, which is putting the pharmaceutical industry under severe pressure. Chemical biology and genomic approaches, primarily monogenic, based on one target-one gene-one disease are not offering desired results. Therefore, there is a need for innovative approaches for drug discovery based on ethnopharmacology, systems biology and holistic targeting.

Most of the drugs recalled or withdrawn over the last half a century are associated with toxic effects on different organs and systems. Among various effects leading to drug recall or withdrawal, hepatic toxicity ranks the highest followed by cardiotoxicity. Specificity to a particular target may not ensure that a drug has no effect on other targets. Systems biology and metabolic network studies with drugs such as thalidomide, rofecoxib, statins, and troglitazone indicate the involvement of on-target pharmacological and off-target nonspecific effects. Drug toxicity is primarily due to cumulative effect of target modulation and intrinsic property of drugs, widely known as “toxicity triangle effect” or “the butterfly effect.” Potential exists for chemical or botanical adjuvants like withanolides, reseveratrol, ginsenosides, and curcumin to alleviate drug-induced toxicities based on modulation of intrinsic properties.

Background: AmrutBhallatak (ABFN02), a 'rasayana' drug from Ayurveda is indicated in degenerative diseases and arthritis. Objective: To evaluate safety and efficacy of ABFN02 in osteoarthritis (OA) and compare it with Glucosamine sulphate (GS) Materials and Methods: This was a r andomized open comparative study. Ambulant OPD patients of OA knees ( n = 112) were enrolled for 24 weeks. Tablets (750mg each) of GS and ABFN02 were matched. Three groups of patients: (A) GS, one tablet × twice/day × 24 weeks. (B) ABFN02, incremental pulse dosage (one tablet x twice/day × two weeks, two tablets × twice/day × two weeks, three tablets × twice/day × two weeks), two such cycles of drug and non-drug phases alternately for six weeks each (C) ABFN02 continuous dosage akin to GS. Pain visual analogue score (Pain-VAS) and Western Ontario and Mc-Master University Osteoarthritis Index (WOMAC) were the primary outcome measures. Secondary outcome measures were Health assessment questionnaire (HAQ), paracetamol consumption, 50 feet walking, physician and patient global assessment, knee stiffness, knee status, urinary CTX II, serum TNFa-SRI, SRII and MRI knee in randomly selected patients. Results: ABFNO2 and GS demonstrated, adherence to treatment 87.75% and 74.3%, reduction in Pain-VAS at rest 61.05% and 57.1%, reduction in pain-VAS on activity 57.4% and 59.8%, WOMAC score drop 62.8% and 59.1% respectively. Secondary outcome measures were comparable in all groups. Safety measures were also comparable. No serious adverse events reported. However, asymptomatic reversible rise in liver enzymes was noted in the ABFNO2 group. Conclusions: ABFN02 has significant activity in OA; the formulation needs further investigation.

A validated in vitro model of cartilage damage and published data were used showing that this model measures the chondroprotective and antiinflammatory effects of different antiarthritic drugs. In this report, this model was used to evaluate the effects of a new antiarthritic Ayurvedic formulation containing Zingiber officinale root, Tinospora cordifolia stem, Phyllanthus emblica fruit and oleoresin of Boswellia serrata. Glucosamine sulphate was used as a positive control in the study. Aqueous extracts of each drug were tested on explant cultures of knee cartilage obtained from osteoarthritis patients undergoing knee replacement surgery. The new formulation caused a sustained and statistically significant inhibition in the release of glycosaminoglycans and aggrecan by cartilage explants from these patients. This formulation also induced a transient antiinflammatory effect as measured by a reduction in the levels of nitric oxide released by explants. Furthermore, the data strongly suggest that oleoresin of B. serrata plays a crucial role in the chondroprotective and antiinflammatory activity of this formulation. In summary, this report provides the first, direct, in vitro biochemical evidence of anti-arthritic activity a new Ayurvedic formulation. This formulation significantly reduced damage of articular knee cartilage from chronic osteoarthritis patients.

Traditional Indian medicine—Ayurveda—classifies the human population into three major constituents orPrakritiknown asVata, PittaandKaphatypes. Earlier, we have demonstrated a proof of concept to support genetic basis forPrakriti. The descriptions in Ayurveda indicate that individuals withPitta Prakritiare fast metabolizers while those ofKapha Prakritiare slow metabolizers. We hypothesized that differentPrakritimay have different drug metabolism rates associated with drug metabolizing enzyme (DME) polymorphism. We didCYP2C19(Phase I DME) genotyping in 132 unrelated healthy subjects of either sex by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) technique. We observed significant association betweenCYP2C19genotype and major classes ofPrakrititypes. The extensive metabolizer (EM) genotype (*1/*1, *1/*2, *1/*3) was found to be predominant inPitta Prakriti(91%). Genotype (*1/*3) specific for EM group was present only inPitta Prakriti.Poor metabolizer (PM) genotype (*2/*2, *2/*3, *3/*3) was highest (31%) inKapha Prakritiwhen compared withVata(12%) andPitta Prakriti(9%). Genotype (*2/*3) which is typical for PM group was significant inKapha Prakriti(odds ratio = 3.5,P= .008).We observed interesting correlations betweenCYP2C19genotypes andPrakritiwith fast and slow metabolism being one of the major distinguishing and differentiating characteristics. These observations are likely to have significant impact on phenotype-genotype correlation, drug discovery, pharmacogenomics and personalized medicine.

Using a validated explant model of in vitro cartilage damage, the effects of aqueous extracts of Withania somnifera (Ashwagandha) root and glucosamine sulphate (GlcS) were tested on the levels of nitric oxide (NO) and glycosaminoglycans (GAGs) secreted by knee cartilage from chronic osteoarthritis (OA) patients. W. somnifera extracts significantly decreased NO release by explants from one subset of patients (antiinflammatory response) and significantly increased levels of NO and GAGs released by explants from the second subset ('non-responders'). This is the first study showing direct, statistically significant, antiinflammatory effects of W. somnifera on human OA cartilage. It also confirmed that glucosamine sulphate exhibited statistically significant, antiinflammatory and chondroprotective activities in human OA cartilage. However, these beneficial effects of GlcS were observed in cartilage explants from 50% of patients tested ('responders'). In contrast, glucosamine significantly increased secretion of NO but not GAGs in explants from the second subset of OA patients ('non-responders'). Cartilage explants from the 11 OA patients gave differential responses to both drugs. Patient samples which responded to the antiinflammatory effects of W. somnifera did not always give a similar response to glucosamine, and vice versa. Thus, this in vitro model of human cartilage damage provides qualitative and statistically significant, quantitative pre-clinical data on antiinflammatory and chondroprotective activities of antiarthritic drugs.

There is a need for effective nutraceuticals for osteoarthritis care. The fruit ofPhyllanthus emblicais used as a powerful rejuvenator in Ayurvedic medicine. This study measured the chondroprotective potential ofP. emblica(‘Amalaki’) fruitsin vitro. We used aqueous extracts of unprocessedP. emblicafruit powder (powder A), and the powder obtained after hot water extraction and drying of powder A (powder B). Chondroprotection was measured in three different assay systems. First, we tested the effects of both fruit powders on the activities of the enzymes hyaluronidase and collagenase type 2. Second, anin vitromodel of cartilage degradation was set-up with explant cultures of articular knee cartilage from osteoarthritis patients. Cartilage damage was assayed by measuring glycosaminoglycan release from explants treated with/withoutP. emblicafruit powders. Aqueous extracts of both fruit powders significantly inhibited the activities of hyaluronidase and collagenase type 2in vitro. Third, in the explant model of cartilage matrix damage, extracts of glucosamine sulphate and powder B (0.05 mg/ml) exhibited statistically significant, long-term chondroprotective activity in cartilage explants from 50% of the patients tested. This result is important since glucosamine sulphate is the leading nutraceutical for osteoarthritis. Powder A induced a statistically significant, short-term chondroprotective activity in cartilage explants from all of the patients tested. This is the first study to identify and quantitate new chondroprotective activities ofP. emblicafruits. These data provide pilot pre-clinical evidence for the use ofP. emblicafruits as a chondroprotective agent in osteoarthritis therapy.

Aim: We evaluated the pharmacogenetic influence of genetic polymorphisms in folate pathway genes in Indian rheumatoid arthritis patients receiving methotrexate (MTX). Patients & methods: Twelve polymorphisms within nine folate pathway genes were analyzed for association with MTX response in 322 Indian rheumatoid arthritis (RA) patients and MTX pharmacokinetics in 94 RA patients. Results: Polymorphisms in GGH, SHMT1 and TS were associated with MTX-related adverse events while SNPs in MTHFR and RFC1/SLC19A1 were associated with MTX efficacy. TS5′UTR and SHMT1 polymorphisms were associated with higher plasma levels of MTX. Conclusion: Polymorphisms in folate-MTX pathway genes contribute to MTX response and affect MTX concentrations in Indian RA patients. A toxicogenetic index could identify patients who develop adverse events to MTX.

The practice of Ayurveda, the traditional medicine of India, is based on the concept of three major constitutional types (Vata, Pitta and Kapha) defined as “Prakriti”. To the best of our knowledge, no study has convincingly correlated genomic variations with the classification of Prakriti. In the present study, we performed genome-wide SNP (single nucleotide polymorphism) analysis (Affymetrix, 6.0) of 262 well-classified male individuals (after screening 3416 subjects) belonging to three Prakritis. We found 52 SNPs (p ≤ 1 × 10−5) were significantly different between Prakritis, without any confounding effect of stratification, after 106 permutations. Principal component analysis (PCA) of these SNPs classified 262 individuals into their respective groups (Vata, Pitta and Kapha) irrespective of their ancestry, which represent its power in categorization. We further validated our finding with 297 Indian population samples with known ancestry. Subsequently, we found that PGM1 correlates with phenotype of Pitta as described in the ancient text of Caraka Samhita, suggesting that the phenotypic classification of India’s traditional medicine has a genetic basis; and its Prakriti-based practice in vogue for many centuries resonates with personalized medicine.

Considerable clinical and experimental evidence now supports the idea that deficiencies or imbalances in certain highly unsaturated fatty acids may contribute to a range of common developmental disorders including Attention Deficit Hyperactivity Disorder (ADHD). Few intervention studies with LCPUFA supplementation have reported inconsistent and marginal results. This pilot study evaluates the effect of alpha linolenic acid (ALA)-rich nutritional supplementation in the form of flax oil and antioxidant emulsion on blood fatty acids composition and behavior in children with ADHD. Post-supplementation levels of RBC membrane fatty acids were significantly higher than pretreatment levels as well as the levels in control. There was significant improvement in the symptoms of ADHD reflected by reduction in total hyperactivity scores of ADHD children derived from ADHD rating scale.

Traditional knowledge-driven bioprospecting offers access to multiple targets that can provide a safer and more cost-effective platform for newer scaffolds to facilitate drug discovery., Modulation of the immune system can be addressed through a variety of specific and non-specific approaches. Many agents of synthetic and natural origin have stimulatory, suppressive or regulatory activity. There is growing evidence that drugs or biological agents capable of modulating single pathways or targets are of limited value as immune-related therapies. Systems biology approaches are now gaining more interest compared with monovalent approaches, which can be of limited benefits with complications. This has stimulated interest in the use of ‘cocktails’ of immunodrugs to restore immunostasis. Botanicals are chemically complex and diverse and could therefore provide appropriate combinations of synergistic moieties useful in drug discovery. Here, the importance of traditional medicine in natural product drug discovery related to immunodrugs is reviewed.

Ayurveda, the traditional Indian medicine (TIM) and traditional Chinese medicine (TCM) remain the most ancient yet living traditions. There has been increased global interest in traditional medicine. Efforts to monitor and regulate herbal drugs and traditional medicine are underway. China has been successful in promoting its therapies with more research and science-based approach, while Ayurveda still needs more extensive scientific research and evidence base. This review gives an overview of basic principles and commonalities of TIM and TCM and discusses key determinants of success, which these great traditions need to address to compete in global markets.

Immunopotentiation on oral feeding of standardized aqueous extract of Withania somnifera (Linn. Dunal, Family Solanaceae) was evaluated in laboratory animals immunized with DPT (Diphtheria, Pertussis, Tetanus) vaccine. The immunostimulation was evaluated using serological and hematological parameters. Treatment of immunized animals with test material (100 mg/kg/day) for 15 days resulted in significant increase of antibody titers to B. pertussis (P=0.000007). Immunized animals (treated and untreated) were challenged with B. pertussis 18,323 strain and the animals were observed for 14 days. Results indicate that the treated animals did show significant increase in antibody titers as compared to untreated animals after challenge (P=0.000003). Immunoprotection against intracerebral challenge of live B. pertussis cells was evaluated based on degree of sickness, paralysis and subsequent death. Reduced mortality accompanied with overall improved health status was observed in treated animals after intracerebral challenge of B. pertussis indicating development of protective immune response. Present study indicates application of the test material as potential immunopotentiating agent possible applications in immunochemical industry. The test material also offers direct therapeutic benefits resulting in reduced morbidity and mortality of experimental animals.

Most of the synthetic chemotherapeutic agents available today are immunosuppressants, cytotoxic, and exert variety of side effects that are particularly evident in cancer chemotherapy. Botanical based immunomodulators are often employed as supportive or adjuvant therapy to overcome the undesired effects of cytotoxic chemotherapeutic agents and to restore normal health. Total extract, polar and non-polar extracts, and their formulations, prepared from medicinal plants mentioned in Ayurveda, namely, Withania somnifera (Linn Dunal) (Solanaceae), Tinospora cordifolia (Miers) (Menispermaceae), and Asparagus racemosus (Willd.) (Liliaceae), exhibited various immunopharmacological activities in cyclophosphamide (CP)-treated mouse ascitic sarcoma. Treatment of ascitic sarcoma-bearing mice with a formulation of total extracts of Withania somnifera and Tinospora cordifolia (80:20) and alkaloid-free polar fraction of Withania somnifera resulted in protection towards CP-induced myelo- and immunoprotection as evident by significant increase in white cell counts and hemagglutinating and hemolytic antibody titers. Treatment with these candidate drugs will be important in development of supportive treatment with cancer chemotherapy.

As this editorial is being written, the Ministry of AYUSH, Government of India has entered into an agreement for collaborative activities in the area of Traditional Medicine with the World Health Organization (WHO), Geneva. This is a strategic decision long overdue. It will help to improve branding and international acceptability of AYUSH systems. Formal collaboration with WHO will entail responsibility on the Government of India to engage in capacity building, advocacy and dissemination of information alongside facilitating scientific research, education, skill development as well as professional practice both in India as well as amongst the Member States of the WHO. Through this milestone agreement it will be possible to create synergies with WHO Traditional Medicine Strategy 2014–2023 and strengthen global visibility of AYUSH systems. This agreement is the second major global milestone, after the United Nations approved June 21st as International Yoga Day last year.