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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.
Register: ChiCTR
Last refreshed on: 22 May 2017
Main ID:  ChiCTR-INR-16009629
Date of registration: 2016-10-26
Prospective Registration: Yes
Primary sponsor: Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine
Public title: A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome
Scientific title: A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome
Date of first enrolment: 2017-04-01
Target sample size: low disease activity-experimental group:27;low disease activity-control group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-con
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=16184
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  New Treatment Measure Clinical Study
Countries of recruitment
China
Contacts
Name: Xue Luan   
Address:  110 Ganhe Road, Shanghai, China
Telephone: +86 18930568151
Email: xelco@163.com
Affiliation:  Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine
Name: Xue Luan   
Address:  110 Ganhe Road, Shanghai, China
Telephone: +86 18930568151
Email: xelco@163.com
Affiliation:  Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine
Key inclusion & exclusion criteria
Inclusion criteria: 1. Age 18~70 years old;
2. Conventional medicine diagnosis according with the 2002 American and European standards for the classification of pSS;
3. TCM disease diagnosis accord with , TCM Syndrome Types diagnosis accord with 1997 National Standard < Clinical terminology of TCM >yin deficiency type and damp heat type.
4. No history of treatment with DMARDs and traditional Chinese medicine in past 8 weeks;
5. If use Glucocorticoid,the prednisone dose must below 10mg/d and stable at least one month.
6. Voluntarily sign informed consent, and comply with the requirements of the research program.

Exclusion criteria: 1. Combined with other connective tissue diseases, drug lupus syndrome, tuberculosis and psychosis;
2. Combined with severe or not control primary diseases in cardiovascular, cerebrovascular, liver, kidney and blood system;
3. ALT or AST is greater than 2 times the upper limit of normal, or total bilirubin is greater than the upper limit of the normal value;
4. With hydroxychloroquine use taboo,like Retinal pigment degeneration, Cardiac conduction; block (PR=0.20sQRS=0.08s);
5. Allergic constitution;
6. Pregnancy, prepare to pregnancy and lactation women;
7. Do not want to participate in or can not strictly comply with the research program requirements;
8. Being in other drug trials;
Those who meet one of the above circumstances, are not included in the test.


Age minimum: 18
Age maximum: 70
Gender: Both
Health Condition(s) or Problem(s) studied
primary Sjogren's Syndrome
Intervention(s)
low disease activity-experimental group:Jiedu Tongluo Shengjin prescription;low disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-experimental group:Jiedu Tongluo Shengjin prescription;moderate disease activity-experimental group:prednisone 10mg/d;moderate disease activity-experimental group:Hydorxychloroquine 0.2g/d;moderate disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-control group:prednisone 10mg/d;moderate disease activity-control group:Hydorxychloroquine 0.2g/d;
Primary Outcome(s)
ESSPRI;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Clinical Research Plan of SHDC
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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