A randomized, double-blind, double-simulated, parally-controlled, multicentre trial for Zhui-Feng Tou-Gu capsule in the treatment of knee osteoarthritis
- Conditions
- Osteoarthritis of knee
- Registration Number
- ITMCTR2000002889
- Lead Sponsor
- ICE of The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Meet the American rheumatology Society (ACR) knee osteoarthritis diagnosis standard, with or without other parts of osteoarthritis;
2. It is in accordance with the diagnostic standard of cold dampness obstruction syndrome of traditional Chinese medicine;
3. Aged 18 to 70 years old;
4. Kellgren Lawrence Grade 1-3 patients;
5. VAS pain score 4 to 7;
6. Patients without surgical treatment (including arthroscopy, plastic surgery, chondrocyte transplantation, etc.);
7. Patients who did not receive intra-articular injection within 30 days;
8. Patients who have taken NSAIDs should stop using NSAIDs for at least 7 days;
9. Patients who have taken glucosamine, chondroitin sulfate and other cartilage protective drugs should stop using them for at least 30 days;
10. Voluntarily sign the informed consent form, and agree to participate in all visits, examinations and treatment in accordance with the requirements of the trial scheme.
1. Patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gouty arthritis and other inflammatory arthritis;
2. Severe and unstable cardiovascular and cerebrovascular diseases (such as unstable angina, coronary vascular regeneration, cerebral vascular regeneration, transient cerebral ischemia attack, congestive heart failure, etc.), acute and uncontrollable diseases, chronic diffuse connective tissue disease, severe hypertension (blood pressure > 160 / 100mmhg) or diabetes mellitus (fasting blood glucose > 11.1mmo) not effectively controlled after treatment L/L);
3. In the past year, there were active peptic ulcer or ulcer with bleeding and perforation;
4.Patients with active liver disease or abnormal liver function (ALT or AST >=upper limit of normal value);
5. Abnormal renal function (SCR >=upper limit of normal value);
6. Those who are allergic to the test drug ingredients;
7. Pregnant, preparing pregnant or lactating women;
8. Those who are participating in other clinical trials;
9. Mental illness, no self-knowledge, unable to express or take medicine on time, unable to cooperate with the completion of the test.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient pain score (VAS);
- Secondary Outcome Measures
Name Time Method TCM syndrome score;WOMAC knee osteoarthritis score;Color ultrasound of knee joint;Number of swollen joints;Number of painful joints;VAS;Use of rescue drugs;Serum MMP-3 level of patients;Serum ESR level of patients;Serum CRP level of patients;