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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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22 July 2019 |
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Main ID: |
ChiCTR1900024642 |
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Date of registration:
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2019-07-19 |
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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 Iguratimod in the Treatment of Primary Sjogren's Syndrome
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Scientific title:
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Clinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome |
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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: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=38804 |
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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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Qin Shao
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Address:
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6 Seventh Panxi Branch Road, Jiangbei District, Chongqing, China
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Telephone:
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+86 15923915463 |
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Email:
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qinshao2011@126.com |
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Affiliation:
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Chongqing Hospital of Traditional Chinese Medicine |
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Name:
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Qin Shao
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Address:
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6 Seventh Panxi Branch Road, Jiangbei District, Chongqing, China
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Telephone:
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+86 15923915463 |
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Email:
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qinshao2011@126.com |
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Affiliation:
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Chongqing Hospital of Traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) Complying with the International Classification Standard of Primary Sjogren's Syndrome revised by ACR/EULAR in 2016;
(2) Aged from 18 to 65 years;
(3) Understand the purpose and steps of the experiment and sign the informed consent.
Exclusion criteria: (1) Secondary Sjogren's syndrome;
(2) Complicated with other connective tissue diseases, lymphoma, AIDS, sarcoidosis, graft-versus-host disease and advanced lymphoid tissue proliferation;
(3) Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system;
(4) Pregnancy, lactation women, allergic constitution;
(5) Used DMARDs drugs within 3 months before admission;
(6) Psychiatric patients and others who can not cooperate.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Sjogren's Syndrome
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Intervention(s)
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Experimental group:Iguratimod+Prednisone;control group:HCQ+Prednisone;
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Primary Outcome(s)
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ESSPRI score;ESSDAI score;ESR;CRP;Ig;
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Source(s) of Monetary Support
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Chongqing Hospital of Traditional Chinese Medcine
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Ethics review
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Status: Approved
Approval date: 15/04/2019
Contact:
Zhi Wei
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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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