A randomized, double blind, placebo-controlled, parallel arm clinical trial of De-Stress and Snooze Gummies in reducing stress, insomnia disorder, associated symptoms and oveall quality of life.
概览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Herbolab India Pvt Ltd
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary outcomes are as follows 1.Changes in perceived stress scale (PSS), Restorative Sleep Questionnaire score-Weekly Version (RSQ-W), Changes in under-eye dark circles for four zones and graded on a bespoke scale, visual analogue score for headache.
概览
简要总结
The current study focuses on clinical validation of efficacy of nutraceutical product in management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. With a good night’s sleep, individuals often find themselves more alert, focused, and better equipped to handle complex tasks and problem-solving scenarios. This can enhance productivity at work, as well as improve the ability to engage in meaningful conversations and activities. Memory consolidation, which occurs during sleep, is also optimized, leading to better retention of information and a sharper mind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female participants aged 21-50 years both inclusive 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 4.Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR 5.Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate 6.Participants with a diagnosis of mild or moderate depression patient’s health questionnaire PHQ-9 score of less than or equal to 14 7.Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10.
排除标准
- •1.Difficulty sleeping due to a medical condition 2.History of a neurological disorder 3.History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication 4.On-going depression and generalized anxiety disorder diagnosis on PHQ 9 score greater than or equal to 15 and GAD-7 score greater than or equal to 11 scales 5.History of substance abuse or dependence 6.History or current evidence of a clinically significant cardiovascular disorder at pre-study visit 7.Taking certain prohibited medications 8.Consumption of greater than 10 cigarettes a day 9.Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study 10.Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent 11.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management 12.Known hypersensitivity to any ingredients of product 13.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study 14.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his her participation in and completion of the protocol.
结局指标
主要结局
Primary outcomes are as follows 1.Changes in perceived stress scale (PSS), Restorative Sleep Questionnaire score-Weekly Version (RSQ-W), Changes in under-eye dark circles for four zones and graded on a bespoke scale, visual analogue score for headache.
时间窗: 1.Screening, day 30 and day 60 | 2.Baseline, day 30 ad day 60 | 3.Score after stopping treatment for 1 week (day 68) | 4.Screening, day 15 and day 60 | 5.Screening, day 30 and day 45 | 6.Screening and day 28
2.Changes in outcomes from participant sleep diary, Sleep efficiency, overall sleep score by actigraphy for 10 subjects
时间窗: 1.Screening, day 30 and day 60 | 2.Baseline, day 30 ad day 60 | 3.Score after stopping treatment for 1 week (day 68) | 4.Screening, day 15 and day 60 | 5.Screening, day 30 and day 45 | 6.Screening and day 28
3.Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ)
时间窗: 1.Screening, day 30 and day 60 | 2.Baseline, day 30 ad day 60 | 3.Score after stopping treatment for 1 week (day 68) | 4.Screening, day 15 and day 60 | 5.Screening, day 30 and day 45 | 6.Screening and day 28
4.Changes in serum cortisol levels at screening, day 15 and day 60
时间窗: 1.Screening, day 30 and day 60 | 2.Baseline, day 30 ad day 60 | 3.Score after stopping treatment for 1 week (day 68) | 4.Screening, day 15 and day 60 | 5.Screening, day 30 and day 45 | 6.Screening and day 28
5.Changes in serum serotonin levels at screening, day 30 and day 45
时间窗: 1.Screening, day 30 and day 60 | 2.Baseline, day 30 ad day 60 | 3.Score after stopping treatment for 1 week (day 68) | 4.Screening, day 15 and day 60 | 5.Screening, day 30 and day 45 | 6.Screening and day 28
6.Changes in Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), Mood State abbreviated version (POMS-A) score
时间窗: 1.Screening, day 30 and day 60 | 2.Baseline, day 30 ad day 60 | 3.Score after stopping treatment for 1 week (day 68) | 4.Screening, day 15 and day 60 | 5.Screening, day 30 and day 45 | 6.Screening and day 28
次要结局
- Secondary outcomes are as follows- 1. Assessment of adverse events, treatment compliance and tolerability of investigational products throughout the study 2.Assessment of changes in vital sign parameters, changes in complete blood count, liver function test and kidney function test.(1.Screening, baseline, day 15, day 30, day 45, day 60, to end of the study)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital