Ginkgo Biloba Extract in the Treatment of Schizophrenia
NCT ID: NCT05258123
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2017-05-15
2018-08-15
Brief Summary
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Detailed Description
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Methods:
1. Clinical Trial: This is a randomized, double-blind and parallel controlled trial in the chronic patients with schizophrenia. The study consists of 12 weeks of double-blind treatment.
2. Assessment Procedures:
2.1 Primary Outcome Variable: Patients were assessed by two clinical trained staff, who were blind to the treatment protocols, by using the Positive and Negative Syndrome Scale (PANSS) to assess the psychopathology and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) to evaluation the cognitive functioning. Patients were interviewed at screening, and at baseline, 4? weeks, 12? weeks.
2.2 Side effects: The side effect rating scale (UKU) was used to assess the side effect at baseline, 4? weeks, and 12? weeks.
2.3 Weight gain measurement: weigh was measured every week.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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active drug
A fixed titration to 360mg （or nine tables） daily of Ginkgo biloba extract was administered with three times daily dosage throughout the study
Ginkgo Biloba Extract
Ginkgo biloba extract with 360mg was administered
placebo
A nine tables of placebo were administered with three times daily dosage throughout the study
Placebo oral tablet
Placebo with nine tables was administered
Interventions
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Ginkgo Biloba Extract
Ginkgo biloba extract with 360mg was administered
Placebo oral tablet
Placebo with nine tables was administered
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 60 years and Han Chinese
* Duration of symptoms at least 12 months
* Current psychotic symptoms of moderate severity
Exclusion Criteria
* Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma；
* Pregnant or breast-feeding female'
* Subjects who suffered from alcohol or illegal durg abuse/dependence
18 Years
60 Years
ALL
Yes
Sponsors
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Beijing HuiLongGuan Hospital
OTHER
Responsible Party
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Xiang Yang Zhang
Professor
Principal Investigators
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Xiang Y Zhang, M.D, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Institute of Psychology, Chinese Academy of Sciences
Locations
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Beijing HuiLongGuan Hospital
Beijing, , China
Countries
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References
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Montes P, Ruiz-Sanchez E, Rojas C, Rojas P. Ginkgo biloba Extract 761: A Review of Basic Studies and Potential Clinical Use in Psychiatric Disorders. CNS Neurol Disord Drug Targets. 2015;14(1):132-49. doi: 10.2174/1871527314666150202151440.
Zheng W, Xiang YQ, Ng CH, Ungvari GS, Chiu HF, Xiang YT. Extract of Ginkgo biloba for Tardive Dyskinesia: Meta-analysis of Randomized Controlled Trials. Pharmacopsychiatry. 2016 May;49(3):107-11. doi: 10.1055/s-0042-102884. Epub 2016 Mar 15.
Zhang WF, Tan YL, Zhang XY, Chan RC, Wu HR, Zhou DF. Extract of Ginkgo biloba treatment for tardive dyskinesia in schizophrenia: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 May;72(5):615-21. doi: 10.4088/JCP.09m05125yel. Epub 2010 Sep 21.
Other Identifiers
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CASPsy4
Identifier Type: -
Identifier Source: org_study_id