ITMCTR2200005674
Not yet recruiting
Phase 2
Clinical study on the efficacy and safety of Kunbi Xiao Prescription in the treatment of female rheumatoid arthritis
Xi Yuan Hospital of China Academy of Chinese Medical Sciences0 sitesTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Xi Yuan Hospital of China Academy of Chinese Medical Sciences
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •? 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.
Outcomes
Primary Outcomes
Not specified
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