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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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18 April 2017 |
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Main ID: |
ChiCTR-TRC-12003542 |
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Date of registration:
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2012-12-18 |
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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 Multi-center, randomized, double-blinded, double-dummy, parallel-controlled clinical trial to determine the efficacy and safety of Tripterygium Glycosides and Acitretin in patients with generalized pustular psoriasis
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Scientific title:
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Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases |
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Date of first enrolment:
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2011-08-01 |
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Target sample size:
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TG treatment group:180;Acitretin treatment group:180; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=6018 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Post-market
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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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Yi Liu
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Address:
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12 Jiangwangmiao Street, Nanjing, China
210042
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Telephone:
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+86 025-85478992 |
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Email:
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hangyezhuanxiang@163.com |
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Affiliation:
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Institute of dermatology, Chinese Academyof Medical Sciences |
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Name:
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Baoxi Wang
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Address:
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12 Jiangwangmiao Street, Nanjing, China
210042
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Telephone:
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+86 025-85478071 |
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Email:
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wangbx@ncstdlc.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Males and females aged between 16 and 75 years;
2. Patients who was diagnosed as generalized pustular psoriasis;
3. Provide written informed consent;
4. Willing and able to comply with all aspects of the protocol.
Exclusion criteria: 1. Localized pustular psoriasis;
2. patients who has allergy of Tripterygium Glycosides and Acitretin any ingredient;
3. Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit eg: corticosteroids, immuno-suppressive drugs, biologics;
4. History of hepatitis B or hepatitis C, and advanced HIV infection;
5. Laboratory data such as alanine aminotransferase (ALT), aspartate aminotransferase (AST) and blood lipid profile was 1.5 times higher than the normal limits.
Age minimum:
16
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Generalized pustular psoriasis
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Intervention(s)
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TG treatment group:Take TG tablet 2 slices every time, thrice a day, the placebo of Acitretin Capsules 2 pills every time, twice a day;Acitretin treatment group:Take the placebo of TG tablet 2 slices every time, thrice a day, Acitretin Capsules 2 pills every time, twice a day;
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Primary Outcome(s)
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The time of no new pustules and the old ones dried;Assessment for the pustule;
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Secondary Outcome(s)
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Skin symptoms and laboratory data of comprehensive;The time of white blood cell and CRP turned to be normalized;Temperature;ESR;hs CRP;
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Source(s) of Monetary Support
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Ministry of Finance of China
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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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