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Ginkgo Biloba Extract in the Treatment of Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ginkgo Biloba Extract
Placebo oral tablet
Sponsored by
Beijing HuiLongGuan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, Ginkgo biloba extract, cognition

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of schizophrenia by two senior psychiatrists
  • Between 18 and 60 years and Han Chinese
  • Duration of symptoms at least 12 months
  • Current psychotic symptoms of moderate severity

Exclusion Criteria:

  • A Diagnostic and Statistical Manual of Mental Disorders IV Axis I diagnosis other than schizophrenia
  • 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

Sites / Locations

  • Beijing HuiLongGuan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

active drug

placebo

Arm Description

A fixed titration to 360mg （or nine tables） daily of Ginkgo biloba extract was administered with three times daily dosage throughout the study

A nine tables of placebo were administered with three times daily dosage throughout the study

Outcomes

Primary Outcome Measures

clinical symptoms
symptoms assessed on PANSS
cognitive functioning
cognitive functioning assessed on RBANS

Secondary Outcome Measures

Side effects
side effect assessed on UKU

Full Information

First Posted
February 24, 2022
Last Updated
February 24, 2022
Sponsor
Beijing HuiLongGuan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05258123
Brief Title
Ginkgo Biloba Extract in the Treatment of Schizophrenia
Official Title
The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
June 12, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing HuiLongGuan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We investigated the effects of Ginkgo biloba extract on the symptoms and cognitive functioning in patients with schizophrenia
Detailed Description
Objective: This study aimed to evaluate the effect of Ginkgo biloba extract in the treatment of symptoms and cognitive functioning in 200? chronic patients with schizophrenia Methods: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, Ginkgo biloba extract, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active drug
Arm Type
Active Comparator
Arm Description
A fixed titration to 360mg （or nine tables） daily of Ginkgo biloba extract was administered with three times daily dosage throughout the study
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
A nine tables of placebo were administered with three times daily dosage throughout the study
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba Extract
Intervention Description
Ginkgo biloba extract with 360mg was administered
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Placebo with nine tables was administered
Primary Outcome Measure Information:
Title
clinical symptoms
Description
symptoms assessed on PANSS
Time Frame
12 weeks
Title
cognitive functioning
Description
cognitive functioning assessed on RBANS
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Side effects
Description
side effect assessed on UKU
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of schizophrenia by two senior psychiatrists Between 18 and 60 years and Han Chinese Duration of symptoms at least 12 months Current psychotic symptoms of moderate severity Exclusion Criteria: A Diagnostic and Statistical Manual of Mental Disorders IV Axis I diagnosis other than schizophrenia 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiang Y Zhang, M.D, Ph.D
Organizational Affiliation
Institute of Psychology, Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
ZIP/Postal Code
100096
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data with be available on request
Citations:
PubMed Identifier
25642989
Citation
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.
Results Reference
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PubMed Identifier
26979525
Citation
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.
Results Reference
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PubMed Identifier
20868638
Citation
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.
Results Reference
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Ginkgo Biloba Extract in the Treatment of Schizophrenia

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