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

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 5, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06674759
Lead Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions
(from sponsor)		 Knee Osteoarthritis (Knee OA)
Related terms Osteoarthritis, Knee
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov