Evaluation of efficacy and safety of EL STI 01 in healthy individuals having stress and insomnia- A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective, Clinical Study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Change in participant-reported total sleep
研究概览
简要总结
It is a randomized, double blind, placebo controlled, multi-centric, interventional, prospective, clinical study to evaluate efficacy and safety of EL/STI/01 in healthy individuals having stress and insomnia. The study will be carried out in 2 to 3 centers across India. Primary objectives of the study will be to assess change in participant-reported total sleep and change in stress on perceived stress scale. Secondary objectives of the study will be to assess changes in sleep efficiency, pre and post-serum cortisol (morning) levels, quality of Life on the GHQ28 Scale, participant-reported time to sleep onset, severity of Insomnia using Insomnia Severity Index, daytime fatigue using Fatigue Severity Scale (FSS), daytime mood, ability to function at work, concentration and memory, quality of sleep on Pittsburgh Sleep Quality Index (PSQI), global assessment for overall change by investigator and by participant, assessment of tolerability of study products and pre and post- study product consumption laboratory investigations.
Summary of Results:
The study concludes that EL/STI/01 which is a combination of herbs and nutraceutical ingredients showed significant stress reducing effects as observed on various scales. Also, there was a significant improvement in the sleep related parameters like total sleep time, sleep efficiency, sleep onset time, and associated symptoms like day time mood, ability to work, concentration, memory. A significant reduction in Sr. Cortisol was observed with 30 days use of EL/STI/01. No adverse event was reported due to the consumption of EL/STI/01 and the same was well tolerated. Laboratory related safety parameters also did not show any significant change with the use of EL/STI/01 providing evidence of safety. EL/STI/01 therefore can be effectively and safely recommended for the management of stress related and sleep related conditions.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Participants who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS)
- •Healthy Participants having insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-5) 3.Insomnia Severity Index more than 7 and greater than 21
- •Participants willing to sign inform consent form 5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period.
排除标准
- •History or diagnosis of another sleep disorder
- •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
- •History of substance abuse or dependence
- •Taking certain prohibited medications [opium, cannabis (marijuana) and methamphetamines]
- •Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer
- •History of malignancy less than or equal to 5 years prior to signing informed consent
- •Known hypersensitivity to any of the ingredients of study products
- •Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol.
结局指标
主要结局
1. Change in participant-reported total sleep
时间窗: Screening Visit Baseline visit, Day 15, Day 30
2. Change in stress on perceived stress scale
时间窗: Screening Visit Baseline visit, Day 15, Day 30
次要结局
- 2. Changes in sleep efficiency(3. Change in pre and post-serum cortisol (morning) levels)
研究者
Dr Vijayalaxmi Sujay Patil
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra