CTRI/2023/11/059422已完成4 期
A randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy of VL-NL-02 on sleep and mood.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- To assess the efficacy of VL-NL-02 on sleep quality using the Insomnia Severity Index questionnaire (ISI).
研究概览
简要总结
Thepresent study is a randomized, placebo-controlled study. 60 individuals will bescreened, and considering a screening failure rate of 20%, approximately 48participants will be randomized in a ratio of 1:1 to receive either VL-NL-02 orplacebo and will be assigned a unique randomization code. Each group will haveat least 20 completed participants after accounting for a dropout/withdrawalrate of 17%. The intervention duration for all the study participants is 21days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged between more than or equal to 18 and less than or equal to 50 years with a moderately active lifestyle as assessed by International Physical Activity Questionnaire.
- •Short form (IPAQ.
- •Individuals with mild to moderate sleeping issues as assessed by an ISI score of more than or equal to 8 and less than or equal to
- •Individuals with a history of at least 3 episodes of sleep disturbances in the last month.
- •Individuals with a Fasting Blood glucose (FBG) less than or equal to 125 mg per dl.
- •All individuals who are free from use of sleeping pills for at least 4 weeks before screening
- •Individuals with normal levels of laboratory parameters: Liver profile, lipid profile and kidney profile.
- •Individuals with no more than once per week use of pain-relieving medications
- •Individuals with body mass index between more than or equal to 18 and less than or equal to 30 kg per m square.
- •Typical bedtime between 9 PM and 11 PM
- •Willing to abstain from digital activity 3 hours prior to the PSG analysis.
- •Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes.
排除标准
- •FBG more than 125 mg per dl
- •Individuals diagnosed with Hypertension.
- •Individuals having a systolic blood pressure more than or equal to 140 mm Hg and diastolic blood pressure more than or equal to 90 mm Hg.
- •Individuals diagnosed with Type I and Type II Diabetes Mellitus
- •Sleep disorder is secondary to another health problem such as restless leg syndrome, post-operative state etc.
- •Individuals diagnosed with insomnia
- •Consumption of hypnotic drugs (less than 3 months before inclusion)
- •Individuals taking any other sleep promoting supplements and are unwilling to stop taking those supplements for the duration of the study period
- •Individuals with history of sleepwalk
- •Individuals who have bad dreams 2 or more times a week
- •Individuals who are inclined to the lifestyle factors – such as jet lag, night workers and rotational shift work
- •Individuals who currently, or in the past 6 months suffered from any mental-health disorder
- •Individuals who were taking psychotropic medication, herbal preparation, antidepressants, steroids, antihistamines, narcotics or any other illicit drugs in the last three months
- •Individuals diagnosed with chronic medical conditions – such as heart problems, Gastro-intestinal, hepatic, respiratory, psychiatric, kidney, or cardiovascular disorder (less than 3 months before inclusion), and chronic pain since last 6 months.
- •Recent (within 3 months before inclusion) change in lifestyle (food, sport and drug)
- •Addiction, history of addiction, and or substance abuse
- •Heavy drinkers as defined by:.
- •For men, consuming more than 4 drinks on any day or more than 14 drinks per week.
- •For women, consuming more than 3 drinks on any day or more than 7 drinks per week
- •Exaggerated consumption of tea (more than or equal to 500 mL per day), coffee (more than or equal to 400 mL per day), or energy drink (more than or equal to 250 mL per day)
- •Individuals on dietary supplements
- •Pregnant or lactating woman
- •Lifestyle habits which would modify the wake-sleep rhythm or which was expected to be modified during the study period (e.g., night work)
- •Known allergy to mushroom.
结局指标
主要结局
To assess the efficacy of VL-NL-02 on sleep quality using the Insomnia Severity Index questionnaire (ISI).
时间窗: Day 0, Day 11 & Day 22
次要结局
- To assess the impact of VL-NL-02 on Mood using Brief Mood Introspection Scale (BMIS)(Day 1, Day 11 & Day 22)
- To assess the impact of VL-NL-02 on Dream as assessed by Dream & Sleep Emotions and Anxiety (DSEA) Questionnaire(Day 1, Day 11 & Day 22)
- To assess the impact of VL-NL-02 on Restorative sleep by using Restorative Sleep Questionnaire - Weekly Version (RSQ-W) questionnaire(Day 1, Day 11 & Day 22)
- To assess the impact of VL-NL-02 on Quality of life using RAND Short form (SF)-36(Day 1, Day 11 & Day 22)
- To assess the impact of VL-NL-02 on Improvement in deep sleep & Rapid eye movement (REM) sleep stages by Polysomnography(Day 0, Day 10 & Day 21)
- To assess the impact of VL-NL-02 on Levels of salivary cortisol immediately after awakening(Day 1 & Day 22)
- To assess the impact of VL-NL-02 on Levels of serum serotonin.(Day 1 & Day 22)
- To assess the impact of VL-NL-02 on Levels of urinary melatonin(Day 1 & Day 22)
- To assess the impact of VL-NL-02 on Levels of serum Brain Derived Neurotrophic Factor (BDNF)(Day 1 & Day 22)
研究者
研究点 (5)
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