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

• Register: ITMCTR
• Last refreshed on: 20 February 2023
• Main ID: ITMCTR2200006093
• Date of registration: 2022-06-11
• Prospective Registration: No
• Primary sponsor: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
• Public title: Evaluation of clinical efficacy of Lv's 'Shu Jin San' in the treatment of rheumatoid arthritis with cold-dampness syndrome
• Scientific title: Evaluation of clinical efficacy of Lv's 'Shu Jin San' in the treatment of rheumatoid arthritis with cold-dampness syndrome
• Date of first enrolment: 2022-06-01
• Target sample size: therapy group:18;control group:18;
• Recruitment status: Recruiting
• URL: http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=51d523f4-4456-4c5a-9250-ac45b1175c78
• Study type: Interventional study
• Study design: Parallel
• Phase: 0

Countries of recruitment

China

Contacts

• Name: Jianye Wang
• Affiliation: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

• Name: Yanqin Bian
• Affiliation: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Key inclusion & exclusion 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
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.

Age minimum: 18
Age maximum: 75
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

therapy group:MTX 10mg po qw + Lv's Shu Jin San 15g po qd;control group:MTX 10mg po qw;

Primary Outcome(s)

Proportion of subjects achieving ACR20 criteria at week 12;

Secondary Outcome(s)

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

Secondary ID(s)

ChiCTR2200060788

ChiMCTR2200006093

Source(s) of Monetary Support

Shanghai Changning District Health Commission

Ethics review

Status: Approved
Approval date: 08/06/2020
Contact:

Dan Zhu