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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
0.72g,2 times a day, oral, for 24 weeks.
0.72g,2 times a day, oral, for 12 weeks.
Changes from Baseline to week 24 in Visual Analog Scale (VAS)score
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in the 30s-CST frequency (30-second chair sit-stand test) of the experimental group relative to the baseline and control group at the 4th, 12th, and 24th weeks;
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in knee osteoarthritis index (WOMAC score) at week 4, week 12, and week 24 relative to baseline and control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in TCM syndrome score evaluation at week 4, week 12, and week 24 relative to baseline and control group;
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in KOOS scores of knee injury and osteoarthritis outcomes at weeks 4, 12, and 24 relative to baseline and the control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in SF-12 at week 4, week 12, and week 24 relative to baseline and control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (CRP) relative to baseline and control group at week 4, week 12, and week 24
CRP in μg/L
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
Changes in serum inflammatory indicators (ESR) relative to baseline and control group at week 4, week 12, and week 24
ESR in mm/h
Time frame: 0 weeks, 4 weeks,12 weeks, 24 weeks
MRI examination of the knee joint (target joint) at the time of enrollment and at week 24 to examine the changes in bone marrow edema, joint effusion, synovitis, cartilage volume and composition relative to the baseline and control group
Time frame: 0 week, 4 weeks,12 weeks, 24 weeks
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