ITMCTR2100005057尚未招募4 期
Prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of Qufengzhitong capsule in the treatment of rheumatoid arthritis
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1.Meet the RA classification standard of American Rheumatology Society (ACR)/ European Union against Rheumatology (EULAR) in 2010;
- •2. TCM syndrome differentiation is wind (cold) dampness obstruction syndrome or liver and kidney deficiency syndrome;
- •3. Aged 18 to 75 years old;
- •4. DAS28(CRP) score > 3.2;
- •5. Before entering the group, the subjects should take glucocorticoid orally, and the dose should be stabilized to be equal to <=10mg/ day prednisone within at least 4 weeks before entering the group, and the dose should remain unchanged after entering the group;
- •6. Traditional anti-rheumatism drugs (DMARDs) and Tripterygium wilfordii preparations were used before entering the group, and the types were limited to one, and they had been treated with stable doses for at least 4 weeks before entering the group, and the dosage remained unchanged after entering the group;
- •7. Before entering the group, the subjects used NSAIDs or other analgesics to treat RA. They must have been treated at a stable dose for at least one week before entering the group, and the dosage remained unchanged after entering the group;
- •8. Volunteer to participate in the experiment and sign the informed consent form.
排除标准
- •1. Those who have been treated with small molecule targeted drugs and biological agents in the past and stopped taking drugs for less than 4 weeks;
- •2. Those who used Qufeng Zhitong Capsule before and stopped taking it for less than 4 weeks;
- •3. Those who have received intra-articular injection, intramuscular injection or intravenous injection of glucocorticoid including adrenocorticotropic hormone within 4 weeks before entering the group;
- •4. Those who have received traditional Chinese medicine decoction or Chinese patent medicine treatment within 1 week before entering the group;
- •5. Those who have used traditional Chinese medicines or proprietary Chinese medicines containing Aconitum carmichaeli, Aconitum carmichaeli, Aconitum kusnezoffii and similar ingredients in the past and stopped using them for less than 4 weeks;
- •6. Pregnancy, breastfeeding and recent family planning;
- •7. Patients with serious diseases such as cardiovascular, brain, liver, lung, kidney and hematopoietic system, acute and chronic infectious diseases, malignant tumors and mental diseases;
- •8. Patients with white blood cell count < 3.0x10^9/L, hemoglobin < 90 g/L, or platelet count < 100.0x10^9/L;
- •9. In the active stage of liver disease or abnormal liver function, AST and ALT are higher than the upper limit of normal value by 1.2 times;
- •10. Abnormal renal function, creatinine (Cr) is higher than the upper limit of normal value by 1.2 times;
- •11. Patients with autoimmune diseases such as systemic lupus erythematosus, scleroderma and Sjogren's syndrome;
- •12. There have been pulmonary interstitial changes in the past:
- •13. Allergic to any known ingredients of methotrexate tablets and Qufeng Zhitong capsules;
- •14. Those who are participating in other trials or who have participated in clinical trials of other drugs within 2 months;
- •15. There are cases where other researchers think that they cannot join this clinical trial.
研究者
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