Acute, subchronic toxicity and genotoxicity studies of JointAlive, a traditional Chinese medicine formulation for knee osteoarthritis

AIM: In vivo and in vitro toxicity tests of JointAlive(®) were studied in animal models to support the safe use of JointAlive(®) as a drug for knee osteoarthritis treatment. METHODS: The acute toxicity study in Sprague Dawley (SD) rats was conducted at a 20 g/kg bw/day dose of JointAlive(®). For 13-week subchronic toxicity tests, SD rats were orally dosed daily with 0.5, 1.5 and 5 g/kg bw/day of JointAlive(®). To assess the potential genotoxicity, Ames test, cellular chromosome aberration and mouse micronucleus test in vivo were carried out. RESULTS: Based on a lack of notable findings other than histopathology finding of co-incidental prostate inflammation at the high dose, the “No Observed Adverse Effect Level (NOAEL)” of JointAlive(®) was concluded as 5 g/kg bw/day in males and females. Results also indicated that JointAlive(®) has no risk of genotoxicity. CONCLUSIONS: General toxicity and genotoxicity studies empirically demonstrated that JointAlive(®) poses a low risk of potential health risks, providing safety supports for the application of JointAlive(®) as a potential drug candidate to treat knee osteoarthritis.