Ginkgo Biloba Extract in the Treatment of Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Ginkgo Biloba Extract; Drug: Placebo oral tablet

• Registration Number: NCT05258123
• Lead Sponsor: Beijing HuiLongGuan Hospital

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:

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.

Study Timeline

• Study Start: 2017-05-15
• Primary Completion: 2018-06-12
• Study Completion: 2018-08-15
• Status Verified: 2022-02
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active drug	Ginkgo Biloba Extract	A fixed titration to 360mg （or nine tables） daily of Ginkgo biloba extract was administered with three times daily dosage throughout the study
placebo	Placebo oral tablet	A nine tables of placebo were administered with three times daily dosage throughout the study

Primary Outcome Measures

Name	Time	Method
cognitive functioning	12 weeks	cognitive functioning assessed on RBANS
clinical symptoms	12 weeks	symptoms assessed on PANSS

Secondary Outcome Measures

Name	Time	Method
Side effects	12 weeks	side effect assessed on UKU

Trial Locations

Locations (1)

Beijing HuiLongGuan Hospital; 🇨🇳 Beijing, China