A prospective, multi-center, randomized, double-blind placebo parallel controlled clinical trial study of Qin's Xiaobi Gel Plaster in the treatment of knee osteoarthritis

适应症

试验速览

阶段: 未知
状态: 尚未招募
发起方: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

暂无简介。

•1. In line with the diagnostic criteria for knee osteoarthritis in the 2018 edition of the Osteoarthritis Diagnosis and Treatment Guidelines of the Joint Surgery Group of the Orthopaedic Branch of the Chinese Medical Association and the 2019 Group Standard of the Rheumatology Branch of the Chinese Medical Association of the Chinese Medicine Association Guidelines for Combination of Osteoarthritis Diseases The diagnostic criteria for damp-heat arthralgia syndrome, patients with Kellgren-Lawrence grades 1 to 3;
•2. Aged 38 to 75 years, regardless of gender (subject to the day of signing the informed consent form);
•3. The patient's self-assessed WOMAC pain score of walking on a flat road surface is >=40mm (>=2 points);
•4. If receiving disease-modifying drug treatment, and the dose is stable for at least 3 months before entering the study, and remains unchanged in subsequent treatment;
•5. No non-steroidal anti-inflammatory drugs or discontinued for at least 5 half-life times
•6. Not taking Chinese herbal decoction or proprietary Chinese medicine for at least 1 week;
•7. Voluntarily join the trial and sign the informed consent form, be able to receive follow-up on time, and abide by the research requirements.

•1. The knee joint has other joint diseases, including but not limited to: tuberculosis, tumor, joint trauma, rheumatoid arthritis, rheumatoid arthritis, gouty arthritis, psoriatic arthritis;
•2. Evaluation of joints who have undergone knee replacement surgery;
•3. Patients with serious primary diseases such as heart, lung, brain, liver, kidney, blood, endocrine, etc. and mental illness;
•4. Pregnant or lactating women;
•5. Active liver disease or abnormal liver function, AST, ALT or GGT higher than 1.5 times the upper limit of normal;
•6. Abnormal renal function, creatinine (Cr) is higher than 1.5 times the upper limit of normal;
•7. Those who are allergic to any component of the study drug;
•8. Those who have received intravenous or intramuscular injection of glucocorticoids within 1 month before enrollment; those who have received oral glucocorticoids within 3 months before enrollment or who have undergone intra-articular injection in the study joint;
•9. Those with skin ulceration or infection in the target joints;
•10. There are various other situations that the investigators consider inappropriate to participate in the clinical study.

发起方