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.
Male or female, aged 40 to 75 years old;
Meet the diagnostic criteria for primary knee osteoarthritis (KOA) (the diagnostic criteria refer to the 1995 American College of Rheumatology classification criteria for knee osteoarthritis);
Meet the diagnostic criteria for liver and kidney deficiency and (or) cold and dampness obstruction in the group standard of the Chinese Association of Traditional Chinese Medicine "Guidelines for Combination of Osteoarthritis Symptoms";
X-ray examination of the joints is graded as I to III (knee joint Kellgren/Lawrence e scoring standard);
Patients with other rheumatic diseases such as Sjögren's syndrome, gout, rheumatoid arthritis, or a history of human immunodeficiency virus (HIV);
Patients with severe lesions of important organs such as the heart, liver, and kidney, abnormal liver function (alanine or aspartate aminotransferase or glutamine transpeptidase>1.5 times the upper limit of normal value); or abnormal renal function (serum creatinine level> upper limit of normal value); white blood cell (white blood cell, WBC) or platelet (platelet, PLT) below the lower limit of normal value; or diabetic patients with poor blood sugar control in the recent period (glycosylated hemoglobin>8.0%);
Patients with suppurative, nonspecific, and other infectious knee arthritis;
Patients with traumatic, villonodular pigmentation and other lesions with knee synovium as the main lesions;
Crossover
Tongren-Dahuoluo Bolus
Drug0.72g,2 times a day, oral, for 24 weeks.
Tongren-Dahuoluo Bolus Placebo
Drug0.72g,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
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;
Changes in knee osteoarthritis index (WOMAC score) at week 4, week 12, and week 24 relative to baseline and control group
Changes in TCM syndrome score evaluation at week 4, week 12, and week 24 relative to baseline and control group;
Changes in KOOS scores of knee injury and osteoarthritis outcomes at weeks 4, 12, and 24 relative to baseline and the control group
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
