UNIM-301 is a coded Unani formulation of CCRUM indicated for pathological conditions involving inflammation like joint pain. UNIM-301 is used clinically but only scanty information is available regarding safety and efficacy. Hence, the present study is designed to investigate 90-day repeated dose oral toxicity study and anti-inflammatory activity in rats. Repeated dose 90-day oral toxicity study was performed as per the limit test method of OECD-408 in Sprague Dawley rats. UNIM-301 was administered at the limit dose of 2,000 mg/kg bw/day (i.e., approximately 10 times of Therapeutically Equivalent Dose). Anti-inflammatory activity of UNIM-301 was evaluated using carrageenan induced paw edema model 100, 200, and 400 mg/kg bw (i.e., 0.5X, 1X and 2X of therapeutic equivalent dose, respectively). In sub-chronic toxicity study, UNIM-301 showed no significant treatment related changes in body weight, feed intake, biochemical and haematological parameters except minor biochemical changes. ALT was significantly raised in male rats while ALP was significantly increased in both sexes treated with UNIM-301. No changes were observed in the gross necropsy and relative organ weights. Histological investigation revealed higher incidence of microvacuolation in the liver of treated rats compared to control group. All the other organs evaluated were found to be normal histologically. Pre-treatment with 100 mg/kg UNIM-301, before carrageenan challenge, significantly (p<0.01) reduced the edema at 6h timepoint. At 200 and 400 mg/kg, UNIM-301 significantly reduced (p<0.01 or p<0.001) the edema at 3, 6 and 24 h and antiinflammatory effect of UNIM-301 was persisted even at 24 h after the carrageenan injection. Data indicates that UNIM-301 is safe at therapeutic dose levels while liver might be the target organ following repeated administration of at very high dose (2000 mg/kg bw/day) in rats. UNIM-301 possesses strong anti-inflammatory potential only at the doses of 200 and 400 mg/kg which validate its traditional use in inflammatory conditions.

Inflammation, Unani, Herbal Medicine, Toxicity, Alternative Therapy