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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-IPR-16008395 |
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Date of registration:
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2016-04-30 |
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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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Vitamin B3 as an adjuvant treatment in schizophrenia: a double-blind, randomized, controlled clinical trial
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Scientific title:
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The clinical safety and efficacy evaluation of Vitamin B3 as an adjuvant treatment in schizophrenia |
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Date of first enrolment:
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2016-06-01 |
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Target sample size:
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Vitamin B3 supplementary group:60;Treat-as-usual Group:60; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=14210 |
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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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Chunling Wan
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Address:
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Little White House, 1954 Huashan Road, Shanghai, China
200030
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Telephone:
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+86 13564485327 |
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Email:
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clwan@sjtu.edu.cn |
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Affiliation:
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Shanghai Jiao Tong University |
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Name:
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Chunling Wan
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Address:
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Little White House, 1954 Huashan Road, Shanghai, China
200030
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Telephone:
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+86 13564485327 |
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Email:
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clwan@sjtu.edu.cn |
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Affiliation:
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Shanghai Jiao Tong University |
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Key inclusion & exclusion criteria
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Inclusion criteria: Diagnosed as schizophrenia according to ICD-10; aged between 18 and 70; inpatients; with informed consent approved;
Exclusion criteria: 1. Within 4 weeks before had participated in other clinical trials;
2. With diabetes, hypertension, gout, autoimmune diseases, neurological diseases, gastrointestinal diseases;
3. With mental symptoms of caused by alcohol or drug abuse or brain injury;
4. Allergic, suffered or are suffering from allergic skin disease;
5. Within two weeks before had taken aspirin and other non steroidal anti-inflammatory drugs, vitamins or lipid supplements;
6. With serious liver and kidney disease;
7. Alcohol or cigarette dependence;
8. Refusal to sign the informed consent form;
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Vitamin B3 supplementary group:with vitamin B3 adjuvant therapy;Treat-as-usual Group:None;
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Primary Outcome(s)
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PANSS score;
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Secondary Outcome(s)
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CGI score;
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Source(s) of Monetary Support
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National Natural Science Fund Committee
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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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