ITMCTR2024000072尚未招募Unknown
Randomized controlled trial of Tibetan medicine for rheumatoid arthritis based on patient preference
Guangdong Provincial Hospital of Traditional Chinese Medicine(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine)0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 75（—）
- 性别
- All
入选标准
- •1. Age between 18 and 75 years old (inclusive), male or female;
- •2. Those who meet the diagnostic criteria of rheumatoid arthritis of Western medicine at the time of screening;
- •3. Meet the Tibetan medicine Changzhong cold syndrome differentiation standards during screening;
- •4. Consistent with the diagnosis of rheumatoid arthritis (2.6= baseline DAS28 score =5.1) in the active stage of moderate and low disease at screening;
- •5. Voluntarily sign the informed consent form;
- •6. Use of traditional disease-modifying antirheumatic drugs (DMARDs) and tripterygium wilfordii preparations before enrollment, and the types are limited to 2 types;
- •7. Have not received DMARDs treatment other than leflunomide, methotrexate, tripterygium, etc. within 1 month before enrollment;
- •8. The use of non-steroidal anti-inflammatory drugs or other analgesics for the treatment of RA before enrollment must have been on a stable dose for at least 1 week before enrollment, and the dose of medication remains unchanged after enrollment;
- •9. Oral glucocorticoids before enrollment, the dose must be stabilized to a dose equivalent to ?10mg/d prednisone for at least 4 weeks before enrollment, and the dose must be maintained unchanged after enrollment.
排除标准
- •1. Patients with other rheumatic immune diseases;
- •2. Patients with severe heart and cerebrovascular diseases, kidney lesions, and liver lesions;
- •3. Patients with serious infections, tumors, and infectious skin diseases;
- •4. Those with advanced deformity, disability, and loss of labor force in rheumatoid arthritis;
- •5. Patients with obvious skin lesions and ulcers at the site of joint lesions;
- •6. Those who are allergic to the test drug;
- •7. Those who are pregnant, or lactating women, or have the possibility of conception but fail to take effective contraceptive measures during the test;
- •8. Subjects with severe organic lesions, mental awareness disorders or other reasons that cannot cooperate with treatment;
- •9. Those who have used biological agents or small molecule targeted drugs in the past 3 months;
- •10. Those who have participated in other interventional clinical trials in the past 1 month or are participating in them;
- •11. Patients with interstitial lung lesions.
研究者
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