Clinical validation of efficacy and safety of Blessful Sleep Gummies (BSG) in subjects suffering from insomnia disorder.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 3. Sleep efficiency (Total sleep time divided by time in bed into 100) derived from subject sleep diary at day 7 and day 14.
研究概览
简要总结
Prevalence of sleep disorder/deprivation is increasing at the alarming levels among the Indian population. Insufficient sleep is a public health epidemic that is often unrecognized and under-reported. The effects of sleep disorders on the body are widely varied across multiple body systems. There are pharmacotherapies to aid in sleep but often are accompanied by adverse events. The micronutrient and phytotherapy supplementation are gaining interest as a sustainable way of handling sleep disorders. In order to validate the hypothesis of usefulness of such interventions in insomnia disorder, BSG is a novel formula tasty gummy format, rather than a pill for better subject compliance.
It is comprising herbal extract, vitamin B6 along with melatonin, which are thought to be effective in management of insomnia and related symptoms.
The present research is an attempt of clinical validation of BSG in subjects suffering from insomnia disorder. With the present research we can apply the knowledge from phytotherapy and nutrition along with the clinical trials to address important medical needs in insomnia subjects to improve sleep. There is need to do primary translational work earliest & focus at some targeted aim and come up with a formulation for same to improve sleep quality and quantity, to improve daytime function, reduction of distress and changes associated with insomnia like fatigue, perceived stress, mood, cortisol and dopamine levels. Which could be achieved through the present research. We can utilize these outcomes to develop a strategy for treating insomnia in more appropriate and assured way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 25.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female aged 25-40 years (both inclusive) at the time of obtaining written informed consent;
- •Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR);
- •Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate;
- •Subjects with a diagnosis of mild or moderate depression (patients’ health questionnaire (PHQ-9) score of less than or equal to 14);
- •Subjects with a diagnosis of mild or moderate generalized anxiety disorder (GAD) -7 questionnaire score of less than or equal to 10;
- •Subjects willing to sign inform consent form;
- •A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period;
- •Willing to limit alcohol, caffeine, and nicotine consumption while in the study.
排除标准
- •Difficulty sleeping due to a medical condition;
- •History of a neurological disorder;
- •History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication;
- •On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score more than or equal to 15 and GAD-7 score more than or equal to 11 scales);
- •History of substance abuse or dependence;
- •History or current evidence of a clinically significant cardiovascular disorder at pre-study visit;7.Taking certain prohibited medications;
- •Consumption of more than 10 cigarettes a day;
- •History of malignancy less than or equal to 5 years prior to signing informed consent and current evidence of cancer;
- •Known hypersensitivity to any ingredients of BSG;
- •Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
3. Sleep efficiency (Total sleep time divided by time in bed into 100) derived from subject sleep diary at day 7 and day 14.
时间窗: Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21)
1. Subject-reported time to sleep onset (as per subject sleep diary) at day 7 and day 14.
时间窗: Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21)
2. Sleep latency (as per subject sleep diary) at day 7 and day 14.
时间窗: Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21)
4. Sleep efficiency (Deep sleep, light sleep and REM sleep duration), overall sleep score by actigraphy for 10 subjects (5 subjects in each group) at screening and day 14.
时间窗: Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21)
次要结局
- 1. Outcomes from subject sleep diary (Subject-reported total sleep time, Subject- reported number of awakenings, Subject -reported wake time after sleep onset) at day 7 and day 14.(2. Severity of insomnia using Insomnia Severity Index Scale at screening and day 14.)