A randomized, placebo-controlled, parallel-group clinical study to evaluate the efficacyand safety of ITC-SLB on sleep quality in healthy subjects having sleep disturbances.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in Actigraphy and Sleep Quality questionnaire scores in comparison with baseline
研究概览
简要总结
This is a double blind, randomized (1:1), placebo controlled, parallel group,two-arm study. Healthy subjects meetingall inclusion and no exclusion criteria after signing a written informed consent will be enrolled in thestudy.After passing the eligibility criteria, subjects will be randomized into 2 treatment arms to receive ITC-SLB(food formulation bar) or placebo in 50:50 ratio. The test formulation (ITC-SLB) or placebo (2 bars) willbe consumed half an hour before sleeping at night, from Day 7 to Day 13.A subgroup of the study population ( who will give consent will be providedwith wrist actigraphy devise which has to be worn on wrist for 14 days for sleep analysis.Subjects will be administered with questionnaires to evaluate the quality of sleep. They will be requested to document the previous nightsleep schedule and quality details in a sleep diary and self-assessment questionnaire every morning.Salivary samples for melatonin analysis will be collected just before the volunteer goes to sleep and next morning(immediately after waking up) on the scheduled days. over all safety and Adverse Events will be also assess during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Urban individuals with NCCS rating of Lower A (A2 and A3) and Higher B (B1) grades 3
- •PSQI scores between 5-15
- •Can read and write English.
- •No history of psychiatric conditions
- •Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages.
- •Should be willing to adhere with their routine diet and exercise regimen throughout the study.
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •Subject suffering from mental disorders, clinical anxiety, depression, Cushing’s syndrome and other major ailments.
- •Subjects on medication/dietary supplements that may affect the measured responses, including medicines for anxiety, depression; prednisone, dexamethasone and other steroids administered orally or intravenous
- •Alcohol addicts, smokers of more than 10 cigarettes/day.
- •Pregnant and lactating women
- •Subjects on hormonal birth-control measures Subjects currently on any medication on a regular basis.
- •Subjects allergic to herbal products, nuts or any component of the study product
- •Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
- •Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Changes in Actigraphy and Sleep Quality questionnaire scores in comparison with baseline
时间窗: Day 0, Day 8, Day 14
次要结局
- Salivary Melatonin level(Day 0, Day 1, Day 7, Day 8, Day 13, Day 14)
- Safety Assessment(Day 0, Day 1, Day 7, Day 8, Day 13, Day 14)