rheumatoid arthritis
Conditions
Interventions
Experimental group:The formula of clearing heat, detoxifying, dispelling dampness and unblocking collaterals combined with methotrexate
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western diagnostic criteria for rheumatoid arthritis; (2) Meets the diagnostic criteria for rheumatoid arthritis with dampness heat toxin syndrome in traditional Chinese medicine; (3) Meets the criteria for determining the active phase of rheumatoid arthritis which is DAS28>3.2 (where C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) can be selected as one of the indicators for calculation and ESR was used in this study); (4) 18 years old = 80 years old; (5) The subjects agree to join this study and sign an informed consent form;
Exclusion criteria
Exclusion criteria: (1) Patients who have used immunosuppressive and steroid drugs related to RA treatment within one month prior to enrollment; (2) Patients with combined inflammatory joint diseases such as psoriatic arthritis, ankylosing spondylitis, gout, etc; (3) Individuals with severe primary diseases of cardiovascular, pulmonary, renal, endocrine, and hematopoietic systems; (4) Have a history of hepatitis B, hepatitis C, tuberculosis, AIDS, acquired immunodeficiency syndrome (AIDS), or malignant tumor; (5) Individuals with severe abnormalities in liver and kidney function; (6) Individuals who are allergic to the components of the experimental drug; (7) Pregnant, preparing for pregnancy or breastfeeding women; (8) Individuals who have participated or are currently participating in other clinical trials within the past month; (9) Mental illness, lack of self-awareness, inability to express accurately or take medication on time, and inability to cooperate in completing the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Health Assessment Questionnaire Disability Index (HAQ-DI);Disease activity DAS28 efficacy;biomarkers;Laboratory indicators;Traditional Chinese Medicine Syndrome Score; | — |
Countries
China
Contacts
Public ContactLiuwei
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed