Ginkgo Biloba Extract in the Treatment of Schizophrenia

Beijing HuiLongGuan Hospital

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Placebo oral tablet; Drug: Ginkgo Biloba Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT05258123

CASPsy4

Details and patient eligibility

About

We investigated the effects of Ginkgo biloba extract on the symptoms and cognitive functioning in patients with schizophrenia

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

active drug

Active Comparator group

Description:

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

Treatment:

Drug: Ginkgo Biloba Extract

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet