Clinical study on Juanbi granule in adjuvant hormone withdrawal of rheumatoid arthritis

Phase 1

Recruiting

• Conditions: rheumatoid arthritis

• Registration Number: ITMCTR2100004610
• Lead Sponsor: Yunnan Hospital of Traditional Chinese Medicine /The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. RA patients who met the 1987 ACR and Medium-to-medical syndrome criteria for diagnosis of cold and dampness syndrome;
2. RA activity subjects with DAS28 score >2.6;
3. Previous use of glucocorticoids (if DAS28 score >= 5.1, take prednisone acetate tablets >= 20mg/ day or equivalent dose of corticosteroids; For patients with 2.6 < DAS28 < 5.1, taking prednisolone acetate >= 10mg/ day or equivalent dose of hormone);
4. Ages 18-65 years, male or female;
5. Those who voluntarily participate in this trial and agree to enter into the clinical study and sign the informed consent.

Exclusion Criteria

1. Had a history of severe respiratory (including pulmonary interstitial fibrosis), blood circulation, digestive, endocrine, urinary diseases and malignant tumors before taking part in the study;
2. Patients with bleeding tendency, active gastrointestinal diseases, and patients with recent surgical history;
3. There is an infection that cannot be controlled by antibiotics, and a history of severe infection or opportunistic infection 2 months before the study;
4. Use of biological agents in recent January;
5. Pregnant and lactating women;
6. Patients participating in other clinical trials;
7. People with allergic constitution (allergic to juanyi granules and hormones);
8. Persons with mental illness;
9. A history of alcohol and drug abuse is suspected or present, or other conditions that reduce the likelihood of inclusion or complicate inclusion, such as frequent changes in the work environment, are likely to cause loss of follow-up.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified