Controlled clinical trial2015Open access

Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study

Kumar G, Srivastava A, Sharma SK, Rao TD, Gupta YK

The Indian journal of medical research · 28 citations

How it was studied

Design
Controlled clinical trial (indexed by PubMed)
Studied in
People
Main outcome
Health markers and function

Who paid for it

Funding
Independent funding

Based on full-text disclosure statement.

Publication

Published
2015-01-01 · Indian J Med Res · vol. 141 · issue 1 · p. 100
Publisher
Medknow
Cited
54 citations · more than 91% of similar papers · 3.2× the field average
Impact
Top 10% most cited in its field
References
33 works
Access
Open access (free to publish)
Research areas
Rheumatoid Arthritis Research and Therapies · Phytochemicals and Medicinal Plants · Pharmacology and Nanomedicine Research
Keywords
Medicine, Rheumatoid arthritis, Internal medicine, Creatinine, Renal function, Rheumatoid factor, Rheumatology, Gastroenterology, Surgery, Traditional medicine
MeSH
humans, arthritis, rheumatoid, plant extracts, medicine, ayurvedic, prospective studies, pilot projects, female, male, patient safety

5 authors

From IN

  • YogendraKumar GuptaAll India Institute of Medical Sciences
  • Amita SrivastavaAll India Institute of Medical Sciences
  • Surinder K. SharmaGovernment of India; Ministry of Health and Family Welfare
  • Gajendra KumarAll India Institute of Medical Sciences
  • T. Uma Maheswara RaoGovernment Ayurvedic College and Hospital

Abstract

Background & objectives

In the traditional system of medicine in India Ashwagandha powder and Sidh Makardhwaj have been used for the treatment of rheumatoid arthritis. However, safety and efficacy of this treatment have not been evaluated. Therefore, the present study was carried out to evaluate the efficacy and safety of Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) in patients with rheumatoid arthritis.

Methods

One hundred and twenty five patients with joint pain were screened at an Ayurvedic hospital in New Delhi, India. Eighty six patients satisfied inclusion criteria and were included in the study. Detailed medical history and physical examination were recorded. Patients took 5g of Ashwagandha powder twice a day for three weeks with lukewarm water or milk. Sidh Makardhwaj (100 mg) with honey was administered daily for the next four weeks. The follow up of patients was carried out every two weeks. The primary efficacy end point was based on American College of Rheumatology (ACR) 20 response. Secondary end points were ACR50, ACR70 responses, change from baseline in disease activity score (DAS) 28 score and ACR parameters. Safety assessments were hepatic function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and ß2 microglobulin], renal function (urea and creatinine and NGAL) tests and urine mercury level.

Results

The study was completed by 90.7 per cent (78/86) patients. Patients with moderate and high disease activity were 57.7 per cent (45/78) and 42.3 per cent (33/78), respectively. All patients were tested positive for rheumatoid factor and increased ESR level. Ashwagandha and Sidh Makardhwaj treatment decreased RA factor. A significant change in post-treatment scores of tender joint counts, swollen joint counts, physician global assessment score, patient global assessment score, pain assessment score, patient self assessed disability index score and ESR level were observed as compared to baseline scores. ACR20 response was observed in 56.4 per cent (44/78) patients (American College of Rheumatology criteria) and moderate response in 39.74 per cent (31/78) patients [European League Against Rheumatism (EULAR) criteria]. Ayurvedic treatment for seven weeks in rheumatoid arthritis patients showed normal kidney and liver function tests. However, increased urinary mercury levels were was observed after treatment.

Interpretation & conclusions

The findings of the present study suggest that this Ayurvedic treatment (Ashwagandha powder and Sidh Makardhwaj) has a potential to be used for the treatment of rheumatoid arthritis. However, due to small sample size, short duration, non randomization and lack of a control group as study limitations, further studies need to be done to confirm these findings.

Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-SA).

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