Clinical study on the changes of intestinal flora before and after Cold Syndrome (Wind-Cold-Dampness-Bi Syndrome) treated by Wenyang Yishen Tongluo Prescriptio
- Conditions
- Rheumatoid arthritis
- Registration Number
- ITMCTR2100004636
- Lead Sponsor
- Yunnan Provincial Hospital of Traditional Chinese medicine / the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Subjects meeting the diagnostic criteria of Western medicine;
2. Patients with RA of wind cold dampness syndrome in accordance with the diagnostic criteria of traditional Chinese medicine;
3. Subjects aged between 18 and 65 years, regardless of gender;
4. Subjects with X-ray stage I or II; joint function grade I, II, III;
5. Subjects with DAS28 score < 4.8;
6. The subjects who are willing to cooperate with the observation and have been followed up for more than 12 weeks can voluntarily cooperate with the implementation of questionnaire survey, routine examination and treatment plan, and sign the informed consent.
1. Patients with other rheumatic immune diseases, such as systemic lupus erythematosus, Sjogren's syndrome, severe osteoarthritis, etc;
2. Subjects with infectious diarrhea within one month;
3. Subjects who had taken antibiotics within one month;
4. Subjects with cardiovascular, pulmonary (pulmonary interstitial fibrosis), liver, gastrointestinal tract, kidney, hematopoietic system or tumor and other serious diseases, or complicated with various acute and chronic infections or other infectious diseases (hepatitis, tuberculosis, etc.);
5. Subjects with contraindications and allergic history of experimental drugs;
6. Subjects with history of alcohol abuse, drug abuse or neuropsychiatric disorders (epilepsy, depression, etc.);
7. Pregnant or lactating women have a family planning in the near future;
8. Subjects who are participating in clinical research of other drugs.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Curative effect of TCM diseases;VAS score for the degree of pain assessed by the patient;Anti-CCP antibodies;C-reactive protein;TCM syndromes are equally divided;The patient assessed the overall condition of the disease VAS score;Rheumatoid factor;Number of joint tenderness;The overall condition VAS score for the disease was assessed by the researchers;DAS28 score;Joint swelling number;Blood sedimentation;
- Secondary Outcome Measures
Name Time Method