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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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2 March 2020 |
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Main ID: |
ChiCTR2000030247 |
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Date of registration:
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2020-02-26 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage
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Scientific title:
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Clinical study of guanxining tablet in the treatment of rheumatoid arthritis with cardiovascular damage |
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Date of first enrolment:
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2020-03-01 |
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Target sample size:
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experimental group:30;control group:30; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=49954 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Wang Wei-jie
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Address:
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318 Chaowang Road, Hangzhou, Zhejiang, China
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Telephone:
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+86 18072946549 |
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Email:
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jack1987168@163.com |
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Affiliation:
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Name:
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Zhu Ming
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Address:
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548 Binwen Road, Hangzhou, Zhejiang, China
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Telephone:
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+86 15700151165 |
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Email:
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627796024@qq.com |
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Affiliation:
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Zhejinag University of f Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) meet the diagnostic criteria of RA, activity period and abnormal heart function;
(2) between the ages of 18 and 60;
(3) if taking NSAIDs, the dose has been stable for at least 4 weeks; if not, it has been stable for at least 1 week;
(4) if you take MTX, you have been treated with MTX3 for at least 4 months, and the dose is fixed at 10mg/ week for at least 4 weeks.If you take LEF, you have been treated with leff for at least 3 months, and the dose is fixed at 10mg/ day for at least 4 weeks.
(5) if glucocorticoid is taken, the dose (compared with prednisone) must be less than 15mg/ day and has been used for at least 4 weeks;
(6) participate in the study voluntarily and sign the informed consent.
Exclusion criteria: (1) intramuscular injection or intravenous drip of glucocorticoids within 4 weeks;
(2) das28-3 score > 5.1 (high activity);
(3) patients with other rheumatic diseases such as systemic lupus erythematosus, sjogren's syndrome and gout;
(4) pregnant or nursing women or those who plan to give birth in the near future;
(5) allergic to the test drugs;
(6) those who have participated in other clinical trials recently (within 1 month);
(7) mental patients and people without capacity for civil conduct.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic lupus erythematosus
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Intervention(s)
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experimental group:Integrative MTX with Guanxinning;control group:MTX;
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Primary Outcome(s)
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SLEDAI;
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Secondary ID(s)
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ChiMCTR2000003055
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Source(s) of Monetary Support
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The Second Affiliated Hospital of Zhejiang Chinese Medical University
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Ethics review
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Status: Approved
Approval date: 06/08/2019
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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