CTRI/2011/11/002130Other1/2 期
An Exploratory, Open Label study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia
试验速览
- 阶段
- 1/2 期
- 状态
- Other
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- •Increase in sleep duration by 1-2 hrs/ day as assessed by patient’s sleep dairy
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of E-IN-05 in subjects with Primary Insomnia. Total 2 sites (one in Mumbai and one in Nasik) have been finalized for the study. Total 20 subjects will be recruited to get 16 completed cases. The total study duration is 42 days with the follow up visits at the interval of 21 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 24.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Case of primary Insomnia as diagnosed by the investigator.
- •Sleep disorder indicated by one or more of the following:.
- •History of sleep duration of less than 4.5 hrs/ night.
- •History of sleep latency of ≥ 60 min.
- •History of tiredness post awakening.
- •History of presence of above symptoms for ≥ 6 months.
- •Able and willing to follow all study related instructions and to make all required visits.
排除标准
- •Subjects not willing to discontinue insomnia medication.
- •Secondary forms of insomnia.
- •Concurrent history/ treatment of acute psychiatric illness (such as schizophrenia, acute panic attack, major depressive disorder etc.).
- •Subjects with history of a substance use disorder.
- •History of uncontrolled diabetes, hypertension and other metabolic disorder.
- •Clinical history of allergy/ hypersensitivity to one or more products of herbal origin.
- •Pregnant / lactating women and women who are planning to get pregnant.
- •Recent (within last 3 months) participation in a clinical trial.
- •Recent (within last 15 days) use of any, herbal or homeopathic product for the insomnia.
- •A medical condition, which in the Investigator’s opinion may pose a threat to patient compliance e.g. case of seizures.
- •Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study.
结局指标
主要结局
•Increase in sleep duration by 1-2 hrs/ day as assessed by patient’s sleep dairy
时间窗: •Increase in sleep duration by 1-2 hrs/ day as assessed by patient’s sleep dairy
次要结局
- 1) Decrease in sleep latency(2) Modified Pittsburgh Sleep Quality Index)
研究者
研究点 (2)
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