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

AimIn vivo and in vitro toxicity tests of JointAlive (R) were studied in animal models to support the safe use of JointAlive (R) as a drug for knee osteoarthritis treatment.MethodsThe acute toxicity study in Sprague Dawley (SD) rats was conducted at a 20 g/kg bw/day dose of JointAlive (R). 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 (R). To assess the potential genotoxicity, Ames test, cellular chromosome aberration and mouse micronucleus test in vivo were carried out.ResultsBased 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 (R) was concluded as 5 g/kg bw/day in males and females. Results also indicated that JointAlive (R) has no risk of genotoxicity.ConclusionsGeneral toxicity and genotoxicity studies empirically demonstrated that JointAlive (R) poses a low risk of potential health risks, providing safety supports for the application of JointAlive (R) as a potential drug candidate to treat knee osteoarthritis.