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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.
Details
| Lead sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
|---|---|
| Phase | PHASE4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 72 |
| Start date | Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Knee Osteoarthritis (Knee OA)
Interventions
- Tongren-Dahuoluo Bolus
- Tongren-Dahuoluo Bolus Placebo