Clinical study on Yupingfengguizhi solution assisted hormone Withdrawal and reduction in rheumatoid arthritis (Wind-Cold-Dampness Arthralgia Syndrome)
- Conditions
- Rheumatoid arthritis
- Registration Number
- ITMCTR2100004239
- Lead Sponsor
- Yunnan Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. According to the ACR rheumatoid arthritis diagnostic criteria of 1987 and TCM diagnostic criteria of wind cold dampness syndrome;
2. Patients with RA disease activity whose DAS28 score is greater than 2.6;
3. Patients who had taken glucocorticoids (prednisone acetate tablets >= 20mg/d or equivalent dose if DAS28 score >= 5.1; Prednisone Acetate Tablets >= 10mg/d or equivalent dose if DAS28 score < 5.1);
4. Aged from 18 to 65 years, male or female;
5. Those who voluntarily participate in the trial and agree to enter the clinical study and sign the informed consent.
1. There was a history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation disorder, digestive, endocrine, urinary system diseases and malignant tumor before the trial;
2. Patients with bleeding tendency, active gastrointestinal disease and recent history of surgery;
3. There was infection that could not be controlled by antibiotics, and there was a history of severe infection or opportunistic infection 2 months before the trial;
4. Biological agents have been used in recent one month;
5. Pregnant and lactating women;
6. Patients participating in other clinical trials;
7. Allergic constitution (allergic to traditional Chinese medicine, hormone and other experimental drugs);
8. Mental patients;
9. Suspected or true history of alcohol or drug abuse, or other diseases that reduce or complicate the possibility of enrollment, such as frequent changes in working environment, are likely to cause loss of follow-up.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hormone withdrawal;DAS28 score;Joint swelling number;Number of joint tenderness;
- Secondary Outcome Measures
Name Time Method ymphocyte subsets;C-reactive protein;Hypersensitive C-reactive protein;ACR20 standard than;Curative effect of TCM diseases;Corticotropin;The patient assessed the overall condition of the disease VAS score;cytokines;The overall condition VAS score for the disease was assessed by the researchers;cortisol;TCM syndromes are equally divided;Health Assessment Questionnaire (HAQ);VAS score for the degree of pain assessed by the patient;Erythrocyte sedimentation rate;