A Randomized, Double-Blind, Multicentric, Placebo-Controlled Clinical Study to Evaluate Efficacy & Safety of HTGF-122105 in Primary Insomnia
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- 1) Change in sleep parameters (Total sleep time, Light sleep, Deep Sleep, REM sleep, No. of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Average resting heart rate, Average resting respiration rate through Actigraphy
研究概览
简要总结
It is a randomized, double-blind, multicentric, placebo-controlled clinical study to evaluate efficacy & safety of HTGF-122105 in primary insomnia. The study will be conducted in 4 centers in India. As per computer generated randomization list, subjects will be randomized to either HTGF-122105 capsule group or similar looking placebo group in 1:1 ratio. Subjects will be asked to take given product in a dose of 2 capsule at bedtime daily with water for 56 days.
The primary objectives will be to assess change in sleep parameters (Total sleep time, Light sleep, Deep Sleep, REM sleep, No. of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Average resting heart rate, Average resting respiration rate through Actigraphy and change in Sleep parameters (Total sleep time, no of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Time to get up after wake up, overall Sleep Quality) through sleep diary.
The secondary objectives of the study will be to assess change in stress as assessed using Stress Mindset Measure (SMM), change in insomnia-related daytime functioning (daytime sleepiness, tiredness, mood disturbances, irritability) on graded scale in natural setting, change in fatigue on VAS, global assessment for overall change by investigator and by subject, tolerability of study product.
Safety of study product assessed through clinical & laboratory assessment (Haematology (CBC), SGOT, Sr. Creatinine, Blood Sugar), and reporting adverse events, and proportion of subjects withdrawing from the study because of adverse events (tolerability) on screening Visit/ Baseline visit (intervention free period), Day 28, Day 56.
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
- •Participants with a) difficulty in initiating sleep, b) staying asleep or waking up early in the morning c) for at least for 3 nights per week d) for at least last 1 month and e) Insomnia with significant distress and persistent preoccupation with deficiency of sleep
- •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.
排除标准
- •History or diagnosis of any other physical, psychological or psychosomatic (including neurological) sleep disorder
- •Subjects with ongoing medications that may be considered contributory to insomnia like psychostimulants, amphetamines, cold medicines, decongestants (like oxymetazoline), beta-agonist, theophylline, caffeine, and any other as determined by the investigator.
- •Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids like prednisone, opioid pain relievers, hypnotics and or prescribed other regular sleep medication.
- •History of bipolar disorder, psychotic disorder including depression and generalized anxiety disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
- •History of substance abuse or dependence
- •Subjects with habit of smoking Cigarette (more than 10 cigarette per day)
- •Subjects with known history of Hepatitis B and or C
- •History of malignancy less than or 5 years prior to signing informed consent
- •Known hypersensitivity to any of the ingredients (Tagara etc.) of study product
- •Other conditions, which in the opinion of the investigators, makes the subject 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 sleep parameters (Total sleep time, Light sleep, Deep Sleep, REM sleep, No. of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Average resting heart rate, Average resting respiration rate through Actigraphy
时间窗: Screening Visit/ Baseline visit (intervention free period), Day 28, Day 56
2) Change in Sleep parameters (Total sleep time, no of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Time to get up after wake up, overall Sleep Quality) through sleep diary
时间窗: Screening Visit/ Baseline visit (intervention free period), Day 28, Day 56
次要结局
- 1. Change in stress as assessed using Stress Mindset Measure (SMM)(2. Change in insomnia-related daytime functioning (daytime sleepiness, tiredness, mood disturbances, irritability) on graded scale in natural setting)
研究者
Dr Sandeep Shinde
Shivam Multispecialty and Accident Care Centre Pvt Ltd