Rheumatoid Arthritis (RA)
Conditions
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Activity Score (DAS28) for 28 joints;American Society of Rheumatology Response Standards; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM Symptoms Scale;Pain VAS Score;HAQ index;Average grip strength of both hands;Rheumatoid factor;Anti-cyclic citrullinated peptide antibody;Erythrocyte sedimentation rate;C-reactive protein;Tumor necrosis factor alpha;IL-6;IL- ß;Vascular endothelial growth factor;Vascular endothelial growth factor receptor 2;Osteoclast differentiation factor;Osteoclast inhibitory factor;X-ray Sharp score;Sex hormone levels; | — |
Countries
China
Contacts
Public ContactKou Qiuai
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed