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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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27 August 2019 |
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Main ID: |
ChiCTR1900024902 |
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Date of registration:
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2019-08-03 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis
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Scientific title:
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A randomized, double-blind, prospective, controlled trial for Yishen-Tongbi-Tang in the treatment of active rheumatoid arthritis |
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Date of first enrolment:
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2019-08-01 |
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Target sample size:
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Experimental group:50;Positive control group:50; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=41411 |
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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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N/A
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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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Guangxing Chen
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Address:
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16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China
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Telephone:
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+86 13711602757 |
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Email:
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cgx02@hotmail.com |
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Affiliation:
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The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine |
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Name:
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Lianyu Zhao
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Address:
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16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China
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Telephone:
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+86 13580407601 |
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Email:
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2677470877@qq.com |
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Affiliation:
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The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Meet the 2010 European League Against Rheumatism and the American College of Rheumatology RA classification criteria and have a RA course of at least 6 weeks;
2. Aged 18-65 years old;
3. AT least three swollen joints (SJC) and five tender joints (TJC);
4. Erythrocyte sedimentation rate (ESR)>28mm/h or C-reactive protein (CRP)>20mg/L;
5. Sign the informed consent form.
Exclusion criteria: 1. pregnant or lactating women;
2. There are fertility requirements at present and in the future;
3. History of chronic severe infection, any current infection and any malignant tumor;
4. Patients with severe primary diseases and mental illnesses such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems;
5. Those with a history of drug allergy;
6. Using disease-modifying anti-rheumatic drugs (DMARDs) and biological disease-modifying anti-rheumatic drugs within the first 3 months of enrollment;
7. The investigator believes that it is not appropriate to participate in this clinical trial.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Experimental group:Traditional Chinese medicine (Yi-Shen Tong-Bi Tang);Positive control group:Methotrexate;
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Primary Outcome(s)
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CDAI;SDAI;
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Secondary Outcome(s)
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DAS28;ACR20;ACR50;ACR70;
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Source(s) of Monetary Support
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Clinical Research Project of the Second Phase of the Innovation and Strengthening Hospital of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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Ethics review
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Status: Approved
Approval date: 10/04/2019
Contact:
Xinying Li
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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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