Aam assessment instrument for disease activity in Aamavata: Scope and challenges.

Development and validation of instruments based on concepts and clinical features described in Ayurveda is a constructive step towards translational research in Ayurveda. The clinical decisions in traditional medical practices often depend on clinical features. Such attempts from Ayurveda experts also contribute to strengthen an endeavour of integrative medicine. A recently published article in J-AIM on development and validation of Aam Assessment Instrument (AAI) to assess the disease activity in amavata is a landmark study. This study is undertaken in patients with rheumatoid arthritis (RA), a prototype of inflammatory arthritis. We suggest that the specificity and reliability of AAI in RA and amavata would increase if complemented with joint count as described in Ayurveda texts. These joint counts can be further sub-classified for different types of inflammatory arthritides. Similarly, this AAI can also be validated and used for constitutional features in other ama-dominant non-rheumatic systemic diseases. This may need development of more comprehensive ama-specific features. We also need to consider the limitations of patient-reported outcome measures (PROMs) during further development and validation of AAI. Collective, multicentric, organized efforts by Ayurveda clinicians will lead to the development of reliable, sensitive, specific, and reproducible instruments for clinical assessments in various diseases.

Picrorhiza kurroa, Royle ex Benth:Traditional uses, phytopharmacology, and translational potential in therapy of fatty liver disease.

Picrorhiza kurroa Royle ex Benth, Kutki (P.kurroa) is an important medicinal plant, traditionally recommended and used in Ayurveda for millennia, with certain cautions. There has been a significant revival of keen interest in its pharmacology, pharmacognosy, and phytochemistry for the last few decades. The evidence of its hepatoprotective activity, in experimental and clinical studies, accelerated the correlation of the specific phytochemical constituents of P.kurroa with precise pharmacological activities. Iridoid glycosides, particularly picrosides, emerged as the active molecules. For effective translation of traditional remedies into modern therapy, value addition by mechanistic understanding of molecular actions, drug targets, the degrees of efficacy and safety as well as convenient dosage forms is needed. Reverse pharmacology approach and phytopharmaceutical drug category facilitate such a translation. The present review illustrates how a potential translation of traditional practices of using P.kurroa into a phytochemically standardized, clinically targeted natural product for global unmet medical needs viz. Fatty liver disease can be attained.

A prospective, randomized, placebo-controlled, double-blind comparative pilot study to evaluate the efficacy of Chlorophytum borivilianum on physical performance.

OBJECTIVES: The objective was to study the adaptogenic effect of Chlorophytum borivilianum (CB) on physical performance when exposed to accustomed activity (AA) and unaccustomed activity (UA) and the effect of CB on heart rate (HR) and blood pressure (BP) in the presence of UA and the effect on muscle strength in comparison with placebo. MATERIALS AND METHODS: A placebo-controlled, double-blind clinical study was initiated after ethics committee approval in healthy volunteers with fixed-dose regimen. Consented volunteers (n = 60) were assigned randomly into two groups of study drug (3 g/day) or placebo (3 g/day) for 2 months. They were evaluated at days 0, 30, and 60 with physical stressors (6-min walk test [6MWT] - distance, HR, and BP; 6-min exercise test [6ETC] - distance, maximum and average speed; and fixed workload test [FWT] - systolic BP, diastolic BP [DBP], and HR on cycle ergometer) and Jammar's dynamometer test for handgrip strength test on each visit. RESULTS: In 6MWT in CB group, distance on day 30 (456 ± 42.1) and day 60 (468.3 ± 0.4) was significantly increased when compared with day 30 (422.6 ± 45.7) and day 60 (419.6 ± 45.1) of the placebo group. On day 60, distance in 6ETC in CB group was 2.92 ± 0.6 which was significantly more than that of placebo group 2.4 ± 0.6. On day 60, in FWT, DBP in the CB group was 75.8 ± 4.4 which was significantly low compared to the placebo group 82.4 ± 7.4 (P < 0.05). CONCLUSION: CB increased physical performance when exposed to AA even after one month and in case of UA increase in performance was seen when CB was administered for two months thus validating its adaptogenic (anti-stress) potential.

A Clinical Study of a Standardized Extract of Leaves of Dalbergia sissoo (Roxb ex DC) in Postmenopausal Osteoporosis.

CONTEXT: Dalbergia sissoo had shown anti-osteoporotic and fracture-healing activities in animal models of postmenopausal osteoporosis (PMO). Standardized extract of leaves of D. sissoo (SEL-Ds) was clinically evaluated for osteoporosis. AIMS: To investigate the anti-osteoporotic activity of D. sissoo in PMO by dual-energy X-ray absorptiometry (DXA), biochemical markers, and effect on clinical profile. Tolerability was assessed by organ function tests and adverse events. SETTINGS AND DESIGN: An open-labeled prospective clinical study in ambulant settings was conducted at the menopausal health-care facility of a women's hospital. MATERIALS AND METHODS: Thirty women (45-69 years) were enrolled for this 1-year study. Evaluations were basally, fortnightly twice, and three monthly four times. SEL-Ds (300 mg) twice daily was administered orally. Calcium (250 mg) and Vitamin D (200 IU) were given twice a day. The efficacy of SEL-Ds was assessed by DXA-scan (spine, femur), by biochemical markers, alkaline phosphatase (ALP), tumor necrosis factor-alpha (TNF-α), and anti-inflammatory marker high-sensitivity C-reactive protein (hs-CRP). Baseline symptom changes and adverse events were carefully recorded. STATISTICAL ANALYSIS: Summary statistics (n, mean, standard deviation, median, and maximum and minimum values) of changes from baseline values and Student's "t-" test for P values were used. RESULTS AND DISCUSSION: SEL-Ds was well tolerated at given dose for 1 year. Anti-osteoporotic and anti-inflammatory activities of SEL-Ds were demonstrated by reduction in TNF-α (12.04 ± 2.81-2.35 ± 1.08 pg/ml), ALP (208.75 ± 45.88-154.52 ± 37.25 IU/L), and hs-CRP (6.1 ± 0.77-3.9 ± 0.47 mg/L). BMD-score on DXA-scan also remained unchanged at majority of the bone locations (increased 13/75, unchanged 51/75, and decreased 08/75). CONCLUSIONS: D. sissoo has demonstrated anti-osteoporotic and anti-inflammatory activities as indicated by decline in circulating TNF-α along with concurrent reduction in ALP. The nondecline in BMD index in the majority confirms the anti-osteoporotic activity.

Panchgavya and cow products: A trail for the holy grail.

For millennia, cow has been central to Indian economy, life and culture. There are innumerable references-Vedic and subsequent to the sacred significance of cow. The benefits of cow have been described at length in relation to agriculture, environment, health, economy and spiritual progress. However, the socio-political issues surrounding cow as a sacred animal have raised acrimonious debates. In Ayurveda also, there is a long tradition of using cow products for positive health, pharmaceutical processes and in therapeutics. There have been quite a few studies on the activity, efficacy, safety and acceptability of Panchagavya and other cow products. Paradoxically, many cow products available in the market for human consumption require improved standardization and proper regulation. Integration of cowpathy (Govaidyak) in traditional Indian systems of medicine has been natural, based on their common dravyagunavigyan. But if its integration with conventional medicine is contemplated, we will need better understanding of the ingredients of cow products, their pharmacokinetics, pharmacodynamics and therapeutic ratio. A rational beginning can be made by data collection of experiential and anecdotal responses. A meticulous analysis of database of panchgavya and other cow products should look for temporal relationships, biological plausibility and translational potential before embarking on state-of-the-art experimental and clinical studies for selected indications.

Effect of Tinospora cordifolia on physical and cardiovascular performance induced by physical stress in healthy human volunteers.

INTRODUCTION: In Ayurveda Tinospora cordifolia (Willd.) Miers., has been used for its Rasayana, Deepana, Jwaranashana, Tridosha Shamaka properties. It is an immunomodulator, useful in stress, hyperlipidemia, pyrexia. T. cordifolia was evaluated for adaptogenic activity in healthy volunteers during exercise. AIMS: The primary objective of this study was to evaluate the effect of T. cordifolia on physical performance, and secondary objectives were to evaluate muscle power, maximal oxygen consumption, and sympathetic activity in comparison with placebo when subjected to physical stress. MATERIALS AND METHODS: A total of thirty participants were randomly assigned into three groups (n = 10 each) namely placebo, TC 150 and TC 300. Placebo group received maize starch capsule, TC 150 and TC 300 received 150 mg and 300 mg, respectively of T. cordifolia aqueous extract in capsule form once daily in the morning for 28 days. The assessment was performed at baseline visit, day 14 and 28. Physical stressors were cycle ergometer exercise, Jammer's hand-held dynamometer, and cold pressor tests. Physical performance evaluated was maximum distance and speed, oxygen consumption (VO2 max), and hand grip strength. Cardiovascular response was assessed by multiple heart rate (HR) and blood pressure (BP) measurements during each test. RESULTS: On day 28, TC 150 mg group showed a significant increase in mean maximum speed compared to placebo. On day 14 and 28, TC 300 mg group showed a significant decrease in mean systolic BP (SBP) and HR on fixed workload exercise compared to placebo. There was significant increasing dose effect of both TC groups on SBP on day 14 and 28 and on HR on day 28 only. On day 14 and 28, TC 300 mg showed a significant decrease in mean HR on the cold pressor test, compared to placebo. CONCLUSION: T. cordifolia improved physical performance and suppressed over activation of the sympathetic nervous system showing its adaptogenic property.

Basti: Does the equipment and method of administration matter?

Basti is one of the five procedures of panchakarma in Ayurveda. Classically, it is advocated in the diseases of vata. It is mainly of two types viz. asthapana and anuvasana. According to the classical texts basti administration is done with the help of animal bladder (bastiputaka) and specially prepared metal/wooden nozzle/catheter (bastinetra), the whole assembly is called as bastiyantra. Nowadays, except in some of the Vaidya traditions in Kerala, basti administration is often done using enema-can or douche-set. In the aforesaid classical procedure active pressure is expected to be given on the bastiputaka whereas, in conventionally used enema-can only passive or gravitational force plays a role. This is important in the context of 'basti danakala or pidanakala i.e. time for basti administration'.

Ayurvedic medicine offers a good alternative to glucosamine and celecoxib in the treatment of symptomatic knee osteoarthritis: a randomized, double-blind, controlled equivalence drug trial.

OBJECTIVE: To demonstrate clinical equivalence between two standardized Ayurveda (India) formulations (SGCG and SGC), glucosamine and celecoxib (NSAID). METHODS: Ayurvedic formulations (extracts of Tinospora cordifolia, Zingiber officinale, Emblica officinalis, Boswellia serrata), glucosamine sulphate (2 g daily) and celecoxib (200 mg daily) were evaluated in a randomized, double-blind, parallel-efficacy, four-arm, multicentre equivalence drug trial of 24 weeks duration. A total of 440 eligible patients suffering from symptomatic knee OA were enrolled and monitored as per protocol. Primary efficacy variables were active body weight-bearing pain (visual analogue scale) and modified WOMAC pain and functional difficulty Likert score (for knee and hip); the corresponding a priori equivalence ranges were ±1.5 cm, ±2.5 and ±8.5. RESULTS: Differences between the intervention arms for mean changes in primary efficacy variables were within the equivalence range by intent-to-treat and per protocol analysis. Twenty-six patients showed asymptomatic increased serum glutamic pyruvic transaminase (SGPT) with otherwise normal liver function; seven patients (Ayurvedic intervention) were withdrawn and SGPT normalized after stopping the drug. Other adverse events were mild and did not differ by intervention. Overall, 28% of patients withdrew from the study. CONCLUSION: In this 6-month controlled study of knee OA, Ayurvedic formulations (especially SGCG) significantly reduced knee pain and improved knee function and were equivalent to glucosamine and celecoxib. The unexpected SGPT rise requires further safety assessment. TRIAL REGISTRATION: Clinical Drug Trial Registry-India, www.ctri.nic.in, CTRI/2008/091/000063.

Comparative study of amrutbhallataka and glucosamine sulphate in osteoarthritis: Six months open label randomized controlled clinical trial.

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 randomized 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.

Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers.

Ashwagandha (Withania somnifera) (WS), a "rasayana" drug, is recommended for balavardhan and mamsavardhan. The study was intended to evaluate dose-related tolerability, safety, and activity of WS formulation in normal individuals. The design was prospective, open-labeled, variable doses in volunteers. Eighteen apparently healthy volunteers (12M:6F, age:18-30 years, and BMI: 19-30) were enrolled. After baseline investigations, they received WS capsules (Rx) (aqueous extract, 8:1) daily in two divided doses with increase in daily dosage every 10 days for 30 days (750 mg/day ×10 days, 1 000 mg/day × 10 days, 1 250 mg/day × 10 days). Volunteers were assessed for symptoms/signs, vital functions, hematological and biochemical organ function tests. Muscle activity was measured by hand grip strength, quadriceps strength, and back extensor force. Exercise tolerance was determined using cycle ergometry. Lean body weight and fat% were computed from skin fold thickness measurement. Adverse events were recorded, as volunteered by the subjects. Repeated measures ANOVA, McNemar's test, and paired t test were employed. All but one volunteer tolerated WS without any adverse event. One volunteer showed increased appetite, libido, and hallucinogenic effects with vertigo at the lowest dose and was withdrawn from study. In six subjects, improvement in quality of sleep was found. Organ function tests were in normal range before and after the intervention. Reduction in total- and LDL- cholesterol and increase of strength in muscle activity was significant. Total body fat percentage showed a reduction trend. WS, in escalated dose, was tolerated well. The formulation appeared safe and strengthened muscle activity. In view of its traditional Rasayana use, further studies are planned to evaluate potential of this drug in patients of sarcopenia.

Comparable efficacy of standardized Ayurveda formulation and hydroxychloroquine sulfate (HCQS) in the treatment of rheumatoid arthritis (RA): a randomized investigator-blind controlled study.

Hydroxychloroquine sulfate (HCQS) is a popular disease-modifying antirheumatic drug (DMARD) despite modest efficacy and toxicity. Ayurveda (ancient India medicinal system) physicians treat rheumatoid arthritis (RA) with allegedly safer herbal formulations. We report a head-to-head comparison in an exploratory drug trial. The objective is to compare standardized Ayurvedic formulations and HCQS in the treatment of RA. One hundred twenty-one patients with active moderately severe RA (ACR 1988 classified) were randomized into a 24-week investigator-blind, parallel efficacy, three-arm (two Ayurvedic and HCQS) multicenter drug trial study; polyherb (Tinospora cordifolia and Zingiber officinale based) and monoherb (Semecarpus anacardium). Study measures included joint counts (pain/tenderness and swelling), pain visual analogue scale, global disease assessments, and health assessment questionnaire. Oral meloxicam (fixed-dosage schedule) was prescribed to all patients during the initial 16 weeks. Patients on prednisolone could continue a fixed stable dose (<7.5 mg daily). Rescue oral use of paracetamol was permitted and monitored. All groups matched well at baseline. An intent-to-treat analysis (ANOVA, significance P < 0.05) did not show significant differences by treatment groups. In the polyherb, monoherb, and HCQS arms, 44%, 36%, and 51%, respectively, showed ACR 20 index improvement. Several efficacy measures improved significantly in the HCQS and polyherb groups with no difference between the groups (corrected P). However, the latter was individually superior to monoherb. Only mild adverse events (gut and skin, and none withdrew) were reported with no differences between the groups. Forty-two patients dropped out. This preliminary drug trial controlled for HCQS demonstrated a standardized Ayurvedic polyherb drug to be effective and safe in controlling active RA. A better-designed study with a longer evaluation period is recommended.

Integrative endeavor for renaissance in Ayurveda.

Currently western medicine has assumed the central position in mainstream global healthcare. Openness to learn from contemporary disciplines of basic sciences, application of modern technology and further adoption of the evidence-based approach has helped western medicine gain its currently acknowledged position as mainstream modern medicine. Modern medicine has further developed forms of integrative medicine by developing interfaces with other systems of medicine, including traditional, complementary and alternative medicine. However, these developments do not seem to address all the problems facing global health care caused by overemphasis on pharmaco-therapeutic drug developments. On the other hand, Ayurveda which is founded on genuine fundamentals, has the longest uninterrupted tradition of healthcare practice, and its holistic approach to healthcare management emphasizes disease prevention and health promotion; if it opens up to incorporate emerging new knowledge into mainstream Ayurveda, and maintains fidelity to Ayurveda fundamentals, it will certainly provide a broad-based opportunity to address the majority of the problems that have emerged from global healthcare requirements. To bring these solutions to bear, however, it will be necessary to progress from the present "utilitarian ethos" to a "unifying ethos" for realization of medical integration.

Complementary and alternative practices in rheumatology.

Hundreds of non-conventional treatment modalities have been used to treat patients with diverse diseases. Whatever term is used, non-conventional remedies, complementary medicine and/or alternative therapies (CAM), or even traditional systems of medicine, have become an increasingly prominent part of health-care utilization by the healthy general population and by patients with various diseases, even in an era of rapidly advancing medical technology. It has become a significant topic not just in the lay press but also in the biomedical literature. Since 1966 more than 46,000 publications that bear this or a related term in titles or abstracts have been referenced in Medline alone. Several important journals have devoted editorials and original papers to this subject during past decade. This review presents the most recent data on the epidemiology of CAM utilization by rheumatic patients, with special emphasis on magnitude and patterns of use, and concepts of alternative versus complementary medicine.