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Completed

NCT Number: NCT05258123

Ginkgo Biloba Extract in the Treatment of Schizophrenia

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing HuiLongGuan Hospital

Beijing, 100096, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo biloba extract

Drug

Ginkgo biloba extract with 360mg was administered

Placebo oral tablet

Drug

Placebo with nine tables was administered

Primary outcomes

  1. clinical symptoms

    Time frame: 12 weeks

    symptoms assessed on PANSS

  2. cognitive functioning

    Time frame: 12 weeks

    cognitive functioning assessed on RBANS

Secondary outcomes

  1. Side effects

    Time frame: 12 weeks

    side effect assessed on UKU

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Registry information

Official study title

The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2022
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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