A study on safety evaluation of Rasnasapthakaya decoction in healthy volunteers

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Background: Rasnasapthakaya (RS) is a decoction o f p o tent anti - inflam m atory herbal preparation which is used to treat' chronic inflam m atory jo in t disorders in ayurvedha m edicine. The constituents o f RS decoction are: A lpinia calcarata, Tinospora cordifolia, Cassia fis tu la , Boerhavia diffusa, Cedrus deodara, Ricinus com m unis and Tribulus testretris. Several scientific studies o f RS decoction in W istar rats revealed th a t th e decoction itself has p o ten t an tiinflam m atory, analgesic, anti-oxidant and anti-histam ine properties. I I Objectives: To determ in e th e safety o f RS in healthy volunteers. M etho d s: Thirty h ealthy volunteers aged 18 - 60 o f eith er sex w ere recruited by open advertisem ent. Every day, freshly prepared RS was distributed in dark bottles (240m l/d ay) fo r 14 days. The participants w ere advised to take 120 ml ('A path a): in th e m orning and night after meals. Blood was draw n on day 0, 8 and 15 for evaluation o f selected liver and kidney function tests. (Serum ALT, AST, ALP, y G T , Creatinine and Urea). Results: According to th e findings o f th e study, th ere w ere no statistically significant (p>0.05) changes observed in day 8 and 15 w hen com pared to th e base line values. Conclusions: RS does not cause any significant adverse effects w ith th e th erapeutic dose used in Ayurvedha.