The Effects of Ginkgo Biloba Extract in the Treatment of Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- clinical symptoms
研究概览
简要总结
We investigated the effects of Ginkgo biloba extract on the symptoms and cognitive functioning in patients with schizophrenia
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Ginkgo Biloba Extract (Drug)
placebo
A nine tables of placebo were administered with three times daily dosage throughout the study
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
clinical symptoms
时间窗: 12 weeks
symptoms assessed on PANSS
cognitive functioning
时间窗: 12 weeks
cognitive functioning assessed on RBANS
次要结局
- Side effects(12 weeks)
研究者
Xiang Yang Zhang
Professor
Beijing HuiLongGuan Hospital