Efficacy and safety of ChondroT on knee-osteoarthritis: Protocol for a 8-week, randomized, double-blind, placebo-controlled, multicenter therapeutic exploratory clinical trial

BACKGROUND: Arthritis is the most common disease in elderly individuals. Many medications for osteoarthritis treatment have the potential for side effects. Using a bioinformatics tool and preclinical studies, ChondroT, 5 herbal complexes, was identified from Ganghwaljetongyeum, which is a18 herbal complex, which has often used to treat osteoarthritis. The goal of this study is to evaluate short-term safety of ChondroT. METHODS: This will be a multicenter, randomized, double-blind, and placebo-controlled trial. There will be a 2-week run-in period before random allocation to 3 groups, ChondroT 1.0 g, 2.0 g, and placebo groups. Total duration of the clinical trial will be 14 weeks including a 4-week washout follow-up. Participants will be followed-up every 4 weeks, and the effect and the safety will be assessed at visit 2, 3, and 4. All participants are asked to maintain the medication schedule in this protocol. The primary outcome will be measured using pain visual analog scale (VAS) after 8 week treatment and secondary outcomes will include pain VAS score after 4 week treatment, SF-36 survey score, patient's global assessment, physical function test, and the change of erythrocyte sedimentation rate, and C-reactive protein. The repeated-measure analysis will be used for the primary efficacy based on full analysis set and per-protocol. DISCUSSION: This study has restrictive inclusion, exclusion criteria, and a well-controlled intervention, and it will be the first randomized controlled trial to evaluate the efficacy and safety of ChondroT formula in osteoarthritis patients. The trial according to this protocol may provide a new intervention in the treatment of osteoarthritis.