A randomized, double-blind, placebo-controlled study of the tricolor ointment for the treatment of osteoarthritic synovitis
- Conditions
- Synovitis
- Registration Number
- ITMCTR2200006804
- Lead Sponsor
- onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Clinical criteria: ? pain in the knee ?Crepitus on active movements ? Morning stiffness=30 min; ?Age=50 years ? swelling of knee joint; ? knee joint distension discomfort or pain; ? When the knee joint is straight or completely flexed, the feeling of distension discomfort or pain is significantly aggravated; ?palpable warmth ? Positive patellar tap test, or excessive effusion in knee joint detected by B-ultrasound or MRI; Patients with ??? and any two other conditions can be diagnosed as knee osteoarthritis synovitis.
?meeting the above diagnostic criteria;?Age 50-70 years;?Kellgren-Lawrence classification belongs to grade 1, 2, 3; (4) The VAS pain score was 4-7; ? Volunteer to participate in this trial, and sign the informed consent.
Exclusion criteria ? women who are preparing to become pregnant or pregnant or breastfeeding; ? Allergic constitution or allergic to known components of the drug used in this test; ? Patients with knee osteoarthritis without swelling, rheumatoid arthritis, rheumatoid arthritis, infectious arthritis, gouty synovitis, synovial tuberculosis, synovioma, hemophilia arthritis, bone tumor, pigmented villonodular synovitis, osteomalacia, multiple myeloma, diabetes mellitus and other serious primary diseases; (4) Hematoma or hyperthyroidism or liver and kidney insufficiency in the knee joint cavity; ? patients with a history of drug abuse, alcoholism, mental illness or Alzheimer's disease; ? Patients who had been treated for synovitis of knee joint within 3 months before the test; ? have participated in other drug clinical trials within 3 months.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method visual analogue scale;WOMAC OSTEOARTHRITIS INDEX;
- Secondary Outcome Measures
Name Time Method Knee Circumference;The range of motion of the knee joint;SF-36 score;