ITMCTR2100004992
Not yet recruiting
Phase 1
Clinical study on effectiveness and safety of Kunbixiao Decoction optimized by Ersi decoction in the treatment of female rheumatoid arthritis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Xiyuan Hospital, 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
- •1\. Female RA patients who meet the diagnostic criteria of Western medicine and TCM syndrome of ''Toxin Heat Phlegm Stasis Accumulation Syndrome'';
- •2\. Aged 18\-65 years;
- •3\. Disease activity score (DAS28\) \> 3\.2 and \<\= 5\.1;
- •4\. Those who did not participate in any drug trials within 4 weeks before enrollment;
- •5\. Volunteer subjects and signed informed consent.
Exclusion Criteria
- •1\. Patients who are pregnant, breastfeeding, planning to become pregnant during treatment and/or within 12 weeks after the end of treatment;
- •2\. Combined with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mental patients;
- •3\. Those who have been diagnosed with other connective tissue diseases such as systemic lupus erythematosus, Sj?gren's syndrome, myositis or dermatomyositis;
- •4\. There are pituitary tumors, hyperthyroidism, ovarian cysts and other diseases affecting endocrine, history of uterine or ovarian surgery, or oral contraceptives within the past 4 weeks;
- •5\. Those who do not meet the requirements for combined medication;
- •6\. Those who are known to be allergic to any traditional Chinese medicine used in this test, or allergic constitution (allergic to two or more drugs, food, and pollen).
- •7\. Those with a history of drug, drug or alcohol abuse;
- •8\. Other conditions deemed inappropriate by the investigator.
Outcomes
Primary Outcomes
Not specified
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