CTRI/2019/05/019431已完成未知
A Randomized, Double Blind, Placebo Controlled Interventional Clinical Study to evaluate the efficacy and safety of Investigational Product SLEPOVIN in patients with Insomnia - Insomnia
BigBrother Nutra Care Pvt Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female subjects aged above 18 years old (inclusive)
- •2. Subject is in good physical status and mental health
- •3. Male or female subjects aged above 18 years old (inclusive)
- •4.Subject is in good physical status and mental health
- •5. Sleep onset insomnia (difficulty taking sleep at the beginning of the night)
- •6. Sleep maintenance insomnia (difficulty in maintaining the sleep)
- •7. Nocturnal awakenings, difficulty in retuning to sleep after awakening in the middle of the night or wakening early in the morning
- •8. Insomnia severity index > 7
- •9. Subject is willing to limit alcohol, caffeine, and nicotine consumption while in the study
- •10. Habitual bedtime between 8.30 pm and midnight
- •11. Able and willing to follow all study related instructions and to complete all required visits
- •12. Subjects willing to give inform consent for participation
排除标准
- •1. Subjects with clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness (es)
- •2. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication
- •3. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea
- •4. Subjects with substance dependence/ abuse in the past one year or with alcohol abuse are ineligible
- •5. Subjects taking certain prohibited medications
- •6. Females who are pregnant, lactating or likely to become pregnant during the study
- •7. Subjects using tobacco products or caffeinated beverages during night awakenings.
- •8. Clinical history of allergy/ hypersensitivity to one or more products of herbal origin. Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 month
研究者
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