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

Exclusion Criteria

• •1. Patients with other rheumatic diseases such as Sjögren's syndrome, gout, rheumatoid arthritis, or a history of human immunodeficiency virus (HIV);
• •2. 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%);
• •3. Patients with suppurative, nonspecific, and other infectious knee arthritis;
• •4. Patients with traumatic, villonodular pigmentation and other lesions with knee synovium as the main lesions;
• •5. Patients with advanced joint deformity or disability; A randomized controlled study on Tongren Dahuoluowan in the treatment of knee osteoarthritis Version number: 2023009P8A01 Version date: December 23, 2022
• •6. Allergic constitution and allergic to the test drug;
• •7. Pregnant, pregnant, or lactating women;
• •8. Those who are taking antidepressants, anticonvulsants, opioids, sedatives and glucocorticoids;
• •9. Patients who have received intra-articular treatment with sodium hyaluronate within 4 weeks before screening; those who have taken drugs containing chondroitin sulfate/glucosamine/diacerein within 3 months before screening; those who have used biological agents within 3 months before screening;
• •10. Patients with organ failure symptoms;
• •11. Those who have participated in any other drug trials within 1 month before selection;