Rheumatism
Conditions
Interventions
Experimental group:Simiaoxiaoling Zhiwang Decoction (granule) + methotrexate + folic acid tablets
Control group:methotrexate + folic acid tablets
Sponsors
Yunnan Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of western medicine for rheumatoid arthritis; 2. RA patients who meet the TCM diagnostic criteria of damp-heat stasis syndrome; 3. Meet the criteria for rheumatoid arthritis disease activity (5.1 > DAS28 score >= 2.6); 4. Aged 18 to 70 years (gender is not limited and includes 18 and 70 years old); 5. Comply with the classification of rheumatoid arthritis joint function standards (in the range of grades I-III); 6. The patient has not used biological agents within 30 days before entering the clinical study; patients who are treated with glucocorticoids should have a stable oral dose of at least 1 month and <=10 mg before entering the clinical study; 7. The patient himself knows and voluntarily participates in this clinical study, agrees to sign the informed consent to enter the clinical study, and can actively cooperate with the doctor in treatment, observation and follow-up.
Exclusion criteria
Exclusion criteria: 1. The age range of the patient is under 18 years old or over 70 years old, and the woman is pregnant, breastfeeding or trying to conceive; 2. In addition to RA, the patient has overlapping other autoimmune diseases, such as severe osteoarthritis, systemic lupus erythematosus, Sj?gren's syndrome, systemic sclerosis, polymyositis/dermatomyositis, silver Psoriatic arthritis, ankylosing spondylitis and other connective tissue diseases; 3. Patients with severe pulmonary interstitial changes, severe damage to liver and kidney functions, liver cirrhosis, tuberculosis, malignant tumors, heart failure, cardiovascular and cerebrovascular, digestive, respiratory and hematopoietic systems and other serious primary diseases; mental patients (in Difficulty in communication in clinical research, or even unable to carry out normal drug treatment); or patients with infectious diseases (such as AIDS, tuberculosis, viral hepatitis, etc.); 4. Past medical history of skin and mucous membranes, digestive tract, internal organ bleeding, coagulation disorders (such as hypercoagulability, thrombocytopenic purpura, etc.), anemia (moderate, severe, extremely severe); 5. Those who need to use immunosuppressants according to the degree of disease development of the patient; or the patient is using biological drugs other than methotrexate; 6. When the patient is screened, the relevant laboratory indicators are abnormal, the total number of white blood cells is less than 3.5 x 10^9/L, the serum creatinine exceeds 1.5 times the upper limit of normal, and the alanine aminotransferase or aspartate aminotransferase is >= 2 times normal. upper limit of value; 7. There are any patients who are not suitable for inclusion in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of joint tenderness;Joint swelling number;Morning stiffness time;DAS28 disease activity score;Evaluation of patient pain (rest pain);Doctor's evaluation of joint pain;Patients' self-evaluation of the current overall condition of the disease;Doctor's score of the patient's overall disease status;Quantitative standard score of Traditional Chinese Medicine Syndrome Classification;Patient reported clinical outcome scale score;Rheumatoid factor typing;Hemorheology;Disease efficacy;ACR20 compliance ratio; | — |
Countries
China
Contacts
Public ContactChen Yanlin
Yunnan Hospital of Traditional Chinese Medicine
Outcome results
None listed