A Single arm, Single blind, Multicenter, Interventional Study to evaluate the Efficacy and Safety of Naturopathic Sleeping Products in Male Patients with General Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Overall improvement in sleep duration (change in Total sleep time (TST) from baseline
研究概览
简要总结
Primary End point
- To evaluate the efficacy and safety of Naturopathic Sleeping Products in Male Patients with General Insomnia.
- Overall improvement in sleep duration, (change in Total sleep time (TST) from baseline.
- The reduction in sleep latency, as the time taken to fall asleep, compared to baseline measurements.
- Improvement in sleep continuity (decrease in number of nighttime awakenings from baseline).
- Improvement in time taken to return to sleep after nighttime awakenings
- Improvement in self-reported alertness 30 minutes after waking
Secondary Endpoint
· To evaluate if any adverse events or abnormal biological markers occur and are associated with the use of the Naturopathic Sleeping Product throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •The person who met ICSD-3 insomnia criteria and determined the following through the CleverSleep SAS tool Participants who are having moderate to severe insomnia Patient must present with normal readings when tested for LFT and eGFR Creatinine levels and Blood Pressure Participants who are willing to take CleverSleep Products for the entire duration of the study Participants who are willing to complete all surveys Participants who are willing to give samples for safety testing.
排除标准
- •Any other sleep disorders Excessive daytime sleepiness of unknown or untreated cause Parasomnias (example sleepwalking night terrors) and sleep-related movement disorders such as restless legs syndrome (RLS) Use of prescription sleep medications within the last 30 days Use of medications included on the exclusion checklist provided No psychiatric (including depression and anxiety) or neurological conditions History of alcohol/substance abuse Shift workers Smokers Diabetes (Type 1 and 2) Major stress event in past 3 months Deprivation index-ensuring socioeconomic consistency and in employment Participants with a child under the age of 5 in the household will be excluded Caregivers whose duties significantly disrupt nighttime sleep will be excluded.
结局指标
主要结局
Overall improvement in sleep duration (change in Total sleep time (TST) from baseline
时间窗: Week 00 | Week 02 | Week 04 | Week 06 | Week 08
The reduction in sleep latency as the time taken to fall asleep, compared to baseline measurements
时间窗: Week 00 | Week 02 | Week 04 | Week 06 | Week 08
Improvement in sleep continuity (decrease in number of nighttime awakenings from baseline
时间窗: Week 00 | Week 02 | Week 04 | Week 06 | Week 08
Improvement in time taken to return to sleep after nighttime awakenings
时间窗: Week 00 | Week 02 | Week 04 | Week 06 | Week 08
Improvement in self-reported alertness 30 minutes after waking
时间窗: Week 00 | Week 02 | Week 04 | Week 06 | Week 08
次要结局
- • If any adverse events (AE) or abnormal biological markers occur during period with their associated incidence and severity reported during the study period(Week 00)
研究者
Dr Anbhazagan Ramaraju
Delta Diabetic Centre