A study on therapeutic efficacy of the herbal decoction Rasna sapthakya in patients with rheumatoid arthritis

INTERVENTION: The seven constituents of Rasna Sapthakaya (RS) decoction are Alpinia calcarata ‐ root Tinospora cordifolia‐ stem Cassia fistula‐ bark of the root Boerhavia diffusa‐ root Cedrus deodara – wood Ricinus communis ‐ root Tribulus testretris‐ whole plant/root The ingredients for the decoction (mentioned above) will be authenticated and the decoction prepared according to the conventional Ayurveda method. 60 patients with rheumatoid arthritis attending the clinic at the Ayurvedha Teaching Hospital, Borella will be recruited by advertisement displayed in the notice boards of the Hospital. Participants meeting inclusion/exclusion criteria will be randomised into two arms. The patients in the intervention arm will be given 14 packets of ingredients of RS decoction. They will be instructed on the method of preparation of the decoction by the principal investigator and the method of preparation also will be provided in writing in their preferred languages. The patients will be advised to take ½ cup which is approximately 120 ml, in the morning and at night, daily for 14 days. The patients on the control arm will receive the standard Ayurveda anti‐inflammatory drug (Rumalaya tablet /500mg/ twice daily for 14 days) at a standard therapeutic dose CONDITION: Rhematoid arthritis PRIMARY OUTCOME: 1. Full blood count; 2. ESR; 3. Rheumatoid factor (RF); 4. Serum anti cyclic citrulinated peptide (Anti‐CCP) antibody; 5. Serum cyclo‐oxygenase 2 (COX 2); 6. Presence of fever; 7. Odema (measured at predetermined location using a standard measuring tape; 8. Joint mobility (using a goniometer) ; SECONDARY OUTCOME: Selected side effects as recorded in a patient diary, including headache, nausea, vomiting, diarrhoea and allergic reactions ( itching, sneezing) INCLUSION CRITERIA: 1. Patients with rheumatoid arthritis, of either sex diagnosed according to the American College of Rheumatology (ACR) criteria for classification of Rheumatoid arthritis (RA) 2. Those who have no history of drug allergy (Ayurvedic or Western).