Clinical study on the efficacy and safety of Kunbi Xiao Prescription in the treatment of female rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- ITMCTR2200005674
- Lead Sponsor
- Xi Yuan Hospital of China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
? 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.
? 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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Activity Score for 28 Joints;
- Secondary Outcome Measures
Name Time Method 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;