osteoarthritis of the knee
Conditions
Interventions
Test Group:Participants in this group will receive Jintiange capsules at a dose of 1.2 grams three times daily for 12 weeks.
Control Group:Participants in this group will receive Aminoglucose Hydrochloride capsules at a dose of 0.75 grams twice daily for 12 weeks.
Sponsors
Shenzhen Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants were required to meet both the following criteria: (1) 40-75 years of age (including 40 and 75 years of age), male and female. (2) a diagnosis of KOA in Western medicine, with a clinical staging of primary. (3) compliance with the diagnostic criteria for osteoarthritis as defined by the 1995 classification criteria of the American College of Rheumatology (ACR). (4) Compliance with the 2023 Chinese Society of Traditional Chinese Medicine (CSTCM) guideline for combined Chinese and Western medicine diagnosis and treatment of osteoarthritis of the knee: "cold dampness obstruction syndrome ,deficiency of the liver and kidney syndrome". (5) Severity of imaging Kellgren Lawrence (K-L) classification = grade III. (6) VAS pain score of 4 (the affected limb with the most obvious pain symptoms was selected). (7) not participating in any drug trial within 1 month before enrollment. (8) body mass index (BMI): 18.5-35 kg.m-2.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions will be excluded from this study: (1) allergic reaction to Gintiange capsules. (2) use of steroids or non-steroidal anti-inflammatory drugs in the past 2 weeks. (3) use of other condition-improving medications ( such as chondroprotectors, etc.) in the past 2 weeks. (4) intra-articular treatment with sodium vitrate or long-acting hormones in the past 1 month. (5) Knee with crystalline synovitis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, systemic lupus erythematosus, dry syndrome, vasculitis, and other rheumatic diseases resulting in inflammatory arthritis and metabolic bone disease caused by endocrine diseases. (6) Combination of serious cardio-cerebral and cerebral vascular diseases; active, recurrent peptic ulcers or other diseases with a hemorrhagic risk; other digestive system serious diseases; malignant tumors, blood, or other systemic serious or progressive diseases. (7) mental diseases or psychological disorders. (8) liver and kidney function: ALT, AST is greater than the upper limit of the normal value, Cr is greater than the upper limit of the normal value (refer to the normal value range of the laboratory test of the research center); or other clinically significant laboratory test abnormalities, and judged by the investigator to be unfit for enrollment. (10) Three months prior to enrollment. (9) Participation in other clinical studies in the 3 months prior to enrollment. (10) Pregnant or lactating women or planned pregnancy in the last 3 months. (11) Other conditions that the researcher deems inappropriate for enrollment in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain scores ; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score and TCM syndrome efficacy;Disappearance rate of clinical symptoms in Chinese medicine;Visual analogue scale (VAS) pain score;Lequesne Functional Index;36-item Short Form Health Survey;erythrocyte sedimentation rate;C-reactive protein; | — |
Countries
China
Contacts
Public ContactXie Jingjing
Shenzhen Hospital of Traditional Chinese Medicine
Outcome results
None listed