NCT06674759

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

Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis: a Randomized, Double-blind, Placebo-controlled Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Knee Osteoarthritis (Knee OA)

Interventions

Type	Name	Description
DRUG	Tongren-Dahuoluo Bolus	0.72g,2 times a day, oral, for 24 weeks.
DRUG	Tongren-Dahuoluo Bolus Placebo	0.72g,2 times a day, oral, for 12 weeks.

Timeline

• Start date: 2025-01-10
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2024-11-05
• Last updated: 2024-11-05