Rheumatoid Arthritis
Conditions
Interventions
Combination therapy group of Yishen Tongbi Decoction with standard treatment:NA
Sponsors
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Eligible participants will be those who satisfy the 2010 classification criteria for rheumatoid arthritis (RA) set forth by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). Additionally, a minimum disease duration of 6 weeks will be required for enrollment. 2.Patients who have received and maintained standard RA treatment for a minimum duration of 4 weeks will be considered eligible for the study. 3.The severity of RA will be assessed based on the Disease Activity Score 28 using either erythrocyte sedimentation rate (DAS28-ESR) or C-reactive protein (DAS28-CRP), categorizing patients into mild, moderate, or severe disease groups. 4.Written informed consent will be obtained from all participants prior to their inclusion in the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women will be excluded from the study. 2.Participants with current or anticipated fertility requirements will not be included in the study. 3.Patients who are currently using Chinese patent medicines or herbal decoctions containing ingredients similar to the investigational drugs will be excluded. 4.Individuals with a history of chronic severe infections, any current infections, or any malignant tumors will be excluded from the study. 5.Patients with severe primary diseases affecting the cardiovascular, cerebrovascular, hepatic, renal, hematopoietic systems, or psychiatric conditions will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| CDAI;SDAI;DAS28;ACR50;ACR70; | — |
Countries
China
Contacts
Public ContactGuangxing Chen
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Baiyun Hospital
Outcome results
None listed