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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-11001193 |
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Date of registration:
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2011-02-22 |
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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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Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial
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Scientific title:
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Tripterygium wilfordii tablets in the treatment of active ankylosing spondylitis: a randomized double-blind, placebo-controlled clinical trial |
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Date of first enrolment:
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2011-01-01 |
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Target sample size:
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Treatment group:66;Control group:22; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8346 |
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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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Yunke Guo
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Address:
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155 Hanzhong Road, Nanjing, Jiangsu, China
210000
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Telephone:
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+86 25 86617141-31012 |
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Email:
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guoyunke316@sina.com |
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Affiliation:
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Jiangsu Provincial Hospital of Traditional Chinese Medicine |
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Name:
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Wei Ji
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Address:
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155 Hanzhong Road, Nanjing, Jiangsu, China
210000
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Telephone:
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+86 25 86617141-31012 |
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Email:
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Weiweiji1103@yahoo.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Between the ages of 18 to 60 years old;
2. Meet the diagnostic criteria for ankylosing spondylitis.
3. BASDAI score >= 4;
4. Spinal pain VAS score >= 4.
Exclusion criteria: (1) DMARDs in the 8 weeks to change drugs, including: hydroxychloroquine, sulfasalazine, methotrexate, thalidomide type or dose;
(2) Changes in the NSAID class of 4 weeks and glucocorticoid type or dose;
(3) Men and women of the future of family planning;
(4) WBC<4*10^9/L;
(5) Abnormal biochemical values: Scr >3.0 mg/dl;
(6) Abnormal biochemical values: ALT more than 2 times the normal figure;
(7) Tripterygium wilfordii have been used without clinical effect;
(8) Associated with other underlying diseases (such as cancer, active tuberculosis), the doctor that is not suitable for those who use Tripterygium wilfordii tablets;
(9) Who are currently suffering from iritis;
(10) Temperature >= 38 degree C;
(11) Hepatitis B patients.
Age minimum:
18
Age maximum:
60
Gender:
Both
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Health Condition(s) or Problem(s) studied
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ankylosing spondylitis
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Intervention(s)
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Treatment group: tripterygium wilfordii tablets ;Control group:Placebo;
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Primary Outcome(s)
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IgA;Liver function;ESR;blood routine test;CRP;
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Source(s) of Monetary Support
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Pharmaceutical Administration of Jiangsu Province (LJ200907)
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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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