Osteoarthritis of knee
Conditions
Interventions
Sponsors
ICE of The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient pain score (VAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactHe Yanlin
Hinye Pharmaceutical Co., Ltd
Outcome results
None listed