Clinical study on treatment of female rheumatoid arthritis by Kunbixiao decoctio
- Conditions
- Rheumatoid Arthritis (RA)
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
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.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease Activity Score (DAS28) for 28 joints;American Society of Rheumatology Response Standards;
- Secondary Outcome Measures
Name Time Method Average grip strength of both hands;Vascular endothelial growth factor;Erythrocyte sedimentation rate;Sex hormone levels;TCM Symptoms Scale;Rheumatoid factor;Anti-cyclic citrullinated peptide antibody;X-ray Sharp score;Tumor necrosis factor alpha;IL- ß;IL-6;Vascular endothelial growth factor receptor 2;Pain VAS Score;Osteoclast inhibitory factor;C-reactive protein;Osteoclast differentiation factor;HAQ index;