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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-12001935 |
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Date of registration:
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2012-02-12 |
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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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Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE
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Scientific title:
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Effect of Detoxification, Removing Stasis and Nourishing Kidney Method on Promoting the Reduction of Prednisone in Treating SLE |
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Date of first enrolment:
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2008-01-12 |
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Target sample size:
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Treatment Group:161;control group:161; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=7613 |
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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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III (Phase III study)
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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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Fan Yongsheng
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Address:
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548 Binwen Road, Hangzhou, China
310053
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Telephone:
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+86 0571 86613587 |
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Email:
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fyszjtcm@163.com |
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Affiliation:
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Name:
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Xie Zhijun
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Address:
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548 Binwen Road, Hangzhou, China
310053
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Telephone:
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+86 13757132498 |
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Email:
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xzj575@163.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: Complying with four or more items in the SLE western medicine diagnosis standard; the patients accord with liver-kidney Yin deficiency toxic heat and blood stasis; the SLE patients in mild- moderate period (SLEDAI between 5 to 14); patients in the age between 18 and 60 years; patients who voluntary to enjoy the test and agree to sign informed consent certificates; patients did not use other related drugs within one week before experimental treatment.
Exclusion criteria: The illness in severe active period; current dosage of prednisone >1mg/kg.d; merge use other immunosuppressive agents beyond glucocorticoid; merge of the fatal damage to target organs; pregnant and lactating women and mental patients; can't tolerate the durgs of the study; diagnosesed as type VI of lupus nephritis or phase V of Chronic nephrosis.
Age minimum:
18
Age maximum:
60
Gender:
Both
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Health Condition(s) or Problem(s) studied
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mild-to-moderate systemic lupus erythematosus
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Intervention(s)
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Treatment Group:treated with prednisone and Jieduquyuzishen recipe;control group:treated with prednisone;
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Primary Outcome(s)
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dosage of prednisone;SLEDAI;Blood routine;Stool routine;Urine routine;Blood biochemistry parameter;
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Secondary Outcome(s)
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TCM syndromes scores;SF-36;AE;
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Source(s) of Monetary Support
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State Ministry of Science and Technique
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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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