NCT02321475已完成不适用
Non-interventional Prospective Observational Study to Describe EGB 761® (Tanakan®) Effectiveness in the Treatment of Patients of Middle Age and Younger With Psycho-emotional Symptoms, Added to Cognitive Disorders.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment
研究概览
简要总结
The purpose of this study is to determine the effectiveness of EGb 761® (Tanakan®) in Russian patients of middle age and younger, suffering from psycho-emotional symptoms added to cognitive disorders based on the improvement of FAM test (feeling-healthy, activity, mood test) score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed the Informed Consent for participation in the observational study before collection of any information
- •Patients who complain of psycho-emotional disturbance (of any intensity)
- •Men and women aged 18-45 years, who prescribed to receive Tanakan® for cognitive disorders
排除标准
- •Presence of any contraindications listed in the Tanakan® local SmPC (hypersensitivity to any of the components of Tanakan®, pregnancy, lactation, erosive gastritis in acute phase, gastric ulcer and duodenum ulcer in acute phase, acute cerebrovascular accident, acute myocardial infarction, congenital galactosemia, lactase deficiency, glucose-galactose malabsorption, haemolysis)
- •Presence of dementia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM IV])
- •Disturbance of usual activities of daily living (e.g. self-care)
- •Patients taking antipsychotic drugs, antidepressants, tranquillisers and nootropic agents
- •Presence of any severe disease or condition which could affect cognitive function (e.g. Parkinson disease, epilepsy, brain inflammatory disease, major depression, recent post-stroke condition, recent brain-trauma etc.);
- •Presence of anxiety or depression according to the Hospital Anxiety and Depression Scale (11 points and more).
研究组 & 干预措施
Psycho-emotional symptoms, added to cognitive disorders
Patients of middle age and younger with psycho-emotional symptoms, added to cognitive disorders.
干预措施: EGb761® (Drug)
结局指标
主要结局
Percentage of patients with increase of total medium FAM test score ≥1 after 3 months treatment
时间窗: 3 months
The FAM test is a questionnaire using three subscales (i.e. General health, Activity, and Mood). Scores for each subscale range from 3 to -3 (where -3 is bad and 3 is good). The total for each subscale and arithmetical mean is calculated.
次要结局
- Change from baseline of attention(3 months)
- Percentage of patients who answered "Completely satisfied", "Rather satisfied", "Neither satisfied nor dissatisfied", "Rather dissatisfied" or "Completely dissatisfied", when assessing their satisfaction with Tanakan®(3 months)
- Change from baseline of total medium FAM test score.(3 months)
- Change from baseline of short-time verbal memory(3 months)
研究者
研究点 (2)
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