A study on safety evaluation of “Rasnasapthakaya” decoction in healthy volunteers

Abstract

BACKGROUND: Rasnasapthakaya (RS) is a decoction of potent anti - inflammatory herbal preparation which is used to treat chronic inflammatory joint disorders in ayurvedha medicine. The constituents of RS decoction are: Alpinia calcarata, Tinospora cordifolia, Cassia fistula, Boerhavia diffusa, Cedrus deodara, Ricinus communis and Tribulus testretris. Several scientific studies of RS decoction in Wistar rats revealed that the decoction itself has potent anti-inflammatory, analgesic, anti-oxidant and anti-histamine properties. OBJECTIVES: To determine the safety of RS in healthy volunteers. METHODS: Thirty healthy volunteers aged 18 – 60 of either sex were recruited by open advertisement. Every day, freshly prepared RS was distributed in dark bottles (240ml/day) for 14 days. The participants were advised to take 120 ml (½ patha) in the morning and night after meals. Blood was drawn on day 0, 8 and 15 for evaluation of selected liver and kidney function tests. (Serum ALT, AST, ALP, γGT , Creatinine and Urea). RESULTS: According to the findings of the study, there were no statistically significant (p>0.05) changes observed in day 8 and 15 when compared to the base line values. CONCLUSIONS: RS does not cause any significant adverse effects with the therapeutic dose used in Ayurvedha.