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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-ONC-15007547 |
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Date of registration:
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2015-12-04 |
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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 theraputic effect of traditional Chinese medicine on systemic lupus erythematosus: a multicenter prospective cohort study
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Scientific title:
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Study of the clinical theraputic effect of traditional Chinese medicine on systemic lupus erythematosus |
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Date of first enrolment:
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2015-12-05 |
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Target sample size:
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The combination of Chinese and western group:264;Treating by Western Medicine group:264; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=12679 |
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Study type:
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Observational study |
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Study design:
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Cohort study
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Phase:
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New Treatment Measure Clinical 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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Chengping Wen
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Address:
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548 Binwen Road, Hangzhou, Zhejiang, China
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Telephone:
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+86 13757132498 |
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Email:
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wengcp@163.com |
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Affiliation:
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Name:
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Zhijun Xie
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Address:
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548 Binwen Road, Hangzhou, Zhejiang, China
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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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Zhejiang Chinese Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) Conform to 4 or more of 11 items of the SLE classification criteria of American rheumatism association in 1997;
(2) in accordance with toxic heat,blood stasis and deficiency of the kidney syndrome of traditional Chinese medicine;
(3) SLEDAI between 5 to 14 points, and the dosage of glucocorticoid (in terms of prednisone) 1 mg/kg.d;
(4) aged between 18 to 60 years old;
(5) volunteered for the experiment and agree to sign the informed consent.
Exclusion criteria: (1) NPSLE patients or patients with lupus crisis;
(2) With complications such as organs severe disease, mental disease, tumor and other diseases;
(3) Cannot tolerate this study's medication;
(4) Pregnant and nursing women;
(5) participating in other clinical trials;
(6) Other reasons are not suitable for clinical subjects, according to the researchers.
Age minimum:
18
Age maximum:
60
Gender:
Both
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Health Condition(s) or Problem(s) studied
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systemic lupus erythematosus
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Intervention(s)
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The combination of Chinese and western group:Traditional Chinese medicine combined western medicine;Treating by Western Medicine group:Treating by Western medicine (sugar cortical hormone, hydroxychloroquine, and methotrexate, azathioprine, or cyclophosphamide);
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Primary Outcome(s)
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SLE disease index;
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Secondary Outcome(s)
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LupusQoL;frequency of Infection;resurgence of diseases;The dosage of glucocorticoid;the time of mild or severe And severe disease outbreaks of disease;Security Index;
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Source(s) of Monetary Support
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National public welfare industry special scientific research projects
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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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