Rheumatoid Arthritis
Conditions
Interventions
The control group:Placebo granules
The test group:Kunbi Xiao granules
Sponsors
Xi Yuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? Female RA patients who meet the diagnostic criteria of Western medicine and TCM syndrome of "Toxic Heat, Phlegm and Blood Stasis Accumulation Syndrome"; ?Age 18-65 years old; ? Disease activity score (DAS28) > 3.2 and = 5.1; ? Those who did not participate in any drug trials within 4 weeks before enrollment; ? Voluntary subjects and signed informed consent.
Exclusion criteria
Exclusion criteria: ? Women who are pregnant, breastfeeding, and plan to become pregnant during treatment and/or within 12 weeks after treatment; ? Patients with serious primary diseases or mental illness such as cardiovascular, liver, kidney and hematopoietic system; ? Patients who have been diagnosed with other connective tissue diseases such as systemic lupus erythematosus, Sj?gren's syndrome, myositis or dermatomyositis; ? Patients with pituitary tumor, hyperthyroidism, ovarian cyst and other endocrine diseases, or have a history of uterine and ovarian surgery, or have taken oral contraceptives in recent 4 weeks; ? Those who do not meet the requirements for combined medication; ? Patients who are known to be allergic to any of the traditional Chinese medicines used in this test, or allergic constitution (allergic to two or more drugs, food, pollen); ? Patients with a history of substance abuse, drug or alcohol abuse; ? Other situations that the researcher considers unsuitable to be selected for this project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score for 28 Joints; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex Hormone Levels;Rheumatoid Factor;ACR Response (ACR20, ACR50, or ACR70);C-reactive protein;Pain Visual Analogue Scale;TCM Syndrome Score;Anti-Cyclic Citrullinated Peptide Antibody;Erythrocyte Sedimentation Rate;Immunoglobulins;Health assessment Questionnaire Score;Complement; | — |
Countries
China
Contacts
Public ContactQiuai Kou
Outcome results
None listed