Evaluation of efficacy & Safety of NST/ST/01 in healthy participants with insomnia- “An Open Label, Single arm, Non- comparative, Interventional, Prospective, Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in sleep parameters (Time in bed, sleep initiation, effective sleep duration, Sleep continuity (Awakenings), tossing and turning, light sleep, NREM (non rapid eye movement) sleep, REM (rapid eye movement) sleep, Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using Ballistocardiography
研究概览
简要总结
It is an open label, single arm, non- comparative, interventional, prospective, clinical study to evaluate efficacy & Safety of NST/ST/01 in healthy participants with insomnia.The study will be carried out at 1 to 2 centers in India. Participants will be asked to take given product in a dose of 1 effervescent tablet at bedtime daily with water for 30 days. The primary objectives of the study will be to assess change in sleep parameters (Time in bed, sleep initiation, effective sleep duration, Sleep continuity (Awakenings), tossing and turning, light sleep, NREM (nonrapid eye movement) sleep, REM (rapid eye movement) sleep, Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using Ballistocardiography. The secondary objectives will be to assess change in severity of Insomnia using Insomnia Severity Index, quality of sleep on Pittsburgh Sleep Quality Index, stress on perceived stress scale, daytime fatigue using Fatigue Severity Scale, daytime mood, ability to function at work, concentration, and memory on a graded scale, change in participant reported total sleep time (as per participant diary), change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset based on participant diary, global assessment for overall change by investigator and by participant, assessment of tolerability of study products by assessing adverse events, and assessment of Laboratory related safety investigations on Screening Visit (up to 3 days), Day 0, Day 15 and Day 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants having average (average of three-night readings before baseline visit) sleep initiation greater than or equal to 30 minutes and effective sleep duration of less than or equal to 6 hours on Ballistocardiography
- •Participants diagnosed with insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR)
- •Insomnia Severity Index score more than 7 and less than or equal to 21
- •Participants willing to sign inform consent form and ready to follow the study protocol requirements
- •Female participants with reproductive potential with a negative pregnancy test (Urine) and agree to use contraception throughout study period
- •Participants willing to stop alcohol, caffeine, and nicotine consumption while in the study.
排除标准
- •Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator)
- •Participants with history of any neurological disorder causing interference in sleep
- •Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
- •Participants with on going depression and generalized anxiety disorder treatment
- •Participants with history of substance abuse or dependence for the last 5 years
- •Participants taking certain prohibited medications like opium, cannabis (marijuana) and methamphetamines etc.
- •Participants with habit of smoking Cigarette etc.
- •(More than 5 cigarettes per day)
- •Participants with known history of hepatitis B and or C
- •Participants with history of malignancy less than or equal to 5 years prior to study participation
- •Participants with known hypersensitivity to any of the ingredients of study products
- •Participants with 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
Change in sleep parameters (Time in bed, sleep initiation, effective sleep duration, Sleep continuity (Awakenings), tossing and turning, light sleep, NREM (non rapid eye movement) sleep, REM (rapid eye movement) sleep, Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using Ballistocardiography
时间窗: Screening Visit (up to 3 days), Day 0, Day 15 and Day 30
次要结局
- 1. Change in severity of Insomnia using Insomnia Severity Index(2. Change in quality of sleep on Pittsburgh Sleep Quality Index)
研究者
Dr Vineet Kumar Malhotra
Vignaharta Health Care Clinic