Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who met the 1987 American College of Rheumatology diagnostic criteria for rheumatoid arthritis; 2. Patients who meet the criteria of liver and kidney deficiency type in the guidelines for diagnosis and treatment of rheumatoid arthritis of rheumatoid arthritis branch of Chinese society of traditional Chinese medicine in 2018; 3. Patients with DAS score above 2.6 and below 5.1; 4. Patients aged 18 and above, 70 and below; 5. Patients have the ability to communicate effectively with the researchers, understand and sign the informed consent, and ensure the compliance of the trial; 6. Women of childbearing age were confirmed to have no pregnancy and had no pregnancy plan during the whole trial period; 7. The chest X-ray of the patient was normal.
Exclusion criteria
Exclusion criteria: 1. Combined with other types of autoimmune, such as: Ankylosing spondylitissystemic lupus erythematosus, scleroderma, etc., or immune Epidemic diseases such as HIV, etc.; 2. Tumor and cancer patients; 3. Patients who underwent surgery within one year, such as joint orthopedic surgery, radical tumor surgery, etc; 4. Patients with allergic constitution or allergic to the test drug or patients with serious adverse reactions such as methotrexate; 5. Lactation and pregnancy women; 6. Patients with mania, depression and other mental disorders; 7. Patients with cholecystitis, peptic ulcer, gastrointestinal inflammation, acute or chronic hepatitis and other digestive system diseases; 8. Urinary system infection, such as acute nephritis, cystitis; 9. Combined with medical diseases such as diabetes, hypertension and hyperlipidemia; 10. Patients with infectious disease history, such as tuberculosis, hepatitis B and HIV carriers; 11. Patients who had a history of opioid analgesics, sedative hypnotics and alcohol abuse; 12. Combined with severe liver and kidney disease or severe damage of liver and kidney function (ALT or ast were 1.5 times higher than the normal upper limit) The serum creatinine level was more than 1.5 times higher than the normal upper limit; 13. Patients with hematological diseases, such as 1) hemoglobin < 9g / dl, or hematocrit < 30%; 2) leucopenia Cell count < 3.0 * 10^9 / L; 3) neutrophil count < 1.2 * 10^9 / L; 4) platelet count < 100 * 10^9 / L; 14. Patients with poor compliance and unable to meet the follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ultrasound;Disease activity scale: ACR20, ACR50, ACR70 and DAS28 ;X-ray: Precise measurement of joint damage, the Van der Heijde Modified Sharp Score ;Inflammatory factors in peripheral blood ;NIR-ICG:Detection of bilateral lymphatic vessels of the upper limb ;Ultrasound:Examination of the underside trochlear lymph node and axillary lymph nodes ;Lymphoid related factors in peripheral blood;Flow cytometry: peripheral blood;Whole transcriptome resequencing:peripheral blood;Metabonomics analysis of blood serum ; | — |
Secondary
| Measure | Time frame |
|---|---|
| HAQ-DI(Health Assessment Questionnaire- Disability Index);Patient Assessment of Arthritis Pain;AIS Sleep Scale;SF-36;syndrome of TCM; | — |
Countries
China
Contacts
Public ContactLiang Qianqian
Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed