A randomized, double-blind, double-simulated, parally-controlled, multicentre trial for Zhui-Feng Tou-Gu capsule in the treatment of knee osteoarthritis

ICE of The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

发起方

ICE of The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine