Evaluation of clinical efficacy of Lv's 'Shu Jin San' in the treatment of rheumatoid arthritis with cold-dampness syndrome

Conditions

Trial Snapshot

Phase: Phase 1
Status: Recruiting
Sponsor: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

No summary available.

•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.

•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.

Sponsor