Rheumatoid Arthritis
Conditions
Interventions
therapy group:MTX 10mg po qw + Lv's Shu Jin San 15g po qd
control group:MTX 10mg po qw
Sponsors
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Those who meet the diagnostic criteria for rheumatoid arthritis, the TCM syndrome is cold-dampness blocking collaterals, and meet the following conditions, are listed as the subjects; (1) Age between 18 and 75 years old (both male and female); (2) Conform to the Declaration of Helsinki and the ethics review of the "Management Regulations for Drug Clinical Research"; (3) 2.6 <DAS28-ESR=5.1; (4) voluntarily fill in the patient's informed consent.
Exclusion criteria
Exclusion criteria: 1) Pregnant women, women planning to become pregnant or breastfeeding; 2) Severe systemic involvement, such as severe pericardial effusion, pulmonary interstitial disease, renal tubular acidosis, atrophic gastritis, autoimmune liver disease, etc.; 3) Active liver disease or abnormal liver function, and ALT and AST are more than 1.2 times the upper limit of normal; 4) Renal damage, serum creatinine greater than 1.6 times the upper limit of normal; 5) Peripheral blood leukocytes <3.5×109/L, hemoglobin <90g/L, platelets <100×109/L, or those with other blood system diseases; 6) Adverse reactions have occurred when using traditional Chinese medicine and methotrexate in the past; 7) Those who used hormones 2 weeks before enrollment; 8) Those who have used MTX alone and have poor disease control; 9) Those who used traditional Chinese medicine or Chinese patent medicine within 2 weeks before enrollment. 10) Those who are participating in other clinical trials; 11) There are various other situations that the investigators believe cannot be included in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving ACR20 criteria at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESR;DAS28;RF;Health Assessment Questionnaire;RA patient-reported clinical outcome (PRO) scale;TNF-a;CRP;IL-ß;IL-6; | — |
Countries
China
Contacts
Public ContactYanqin Bian
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed