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

Phase 1

Recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: ITMCTR2200006093
• Lead Sponsor: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving ACR20 criteria at week 12;

Secondary Outcome Measures

Name	Time	Method
ESR;DAS28;RF;Health Assessment Questionnaire;RA patient-reported clinical outcome (PRO) scale;TNF-a;CRP;IL-ß;IL-6;