Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis

The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and/or cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the control group (Tongren-Dahuoluo Bolus) and the treatment group (Tongren-Dahuoluo Bolus Placebo) in a 1:1 ratio. The purpose is to compare the safety and efficacy of Tongren-Dahuoluo Bolus and placebo in treating knee osteoarthritis. A long-term blind extension study will be conducted in the next 12 weeks. All subjects will take Tongren-Dahuoluo Bolus orally to evaluate the long-term safety, tolerability, and efficacy of Tongren-Dahuoluo Pills in treating patients with knee osteoarthritis.

NCT Number	NCT06674759
Lead Sponsor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions	Knee Osteoarthritis (Knee OA)
Enrollment	72 participants
Start Date	2025-01-10
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-12-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-05