A Randomized, double blind, placebo controlled, multicentric, interventional Prospective, clinical Study to evaluate efficacy and safety of Sleep Rhythm Capsules (SRC) in healthy participants with mild to moderate sleep disturbances
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Change in sleep parameters [Onset of sleep latency (SOL), Sleep Efficiency (SE), Total Bed time (TBT), Total Sleep Time (TST), Wake after Sleep Onset (WASO), Light Sleep, Deep Sleep, REM Sleep,] using Actigraphy
研究概览
简要总结
It is a Randomized, Controlled,Double Blind clinical study to evaluate efficacy and safety of Sleep Rhythm Capsules (SRC) in healthy participants with mild to moderate sleep disturbances. The study will be carried out in 2-3 centers in India. As per computer generated randomization list, subjects will be assigned to either of the two groups (study product or placebo) in 1 :1 ratio. Subjects will be asked to take given product in a dose of 2 capsule at bedtime for 30 days. Primary objectives of the study will be to assess sleep parameters [Onset of sleep latency (SOL), Sleep Efficiency (SE), Total Bed time (TBT), Total Sleep Time (TST), Wake after Sleep Onset (WASO), Light Sleep, Deep Sleep, REM Sleep,] using Actigraphy and sleep efficiency (Total sleep time/ Time in bed*100) time of sleep onset, number of awakenings and wake time after sleep onset, (as per participant diary). The secondary objectives of the study will be to assess change in severity of sleep disturbance using Insomnia Severity Index, change in daytime fatigue using Fatigue Severity Scale (FSS), Change in daytime mood, ability to function at work, concentration, on a graded scale (VAS), change in Quality of sleep on Pittsburgh Sleep Quality Index (PSQI), change in stress assessed on perceived stress scale (PSS), global assessment for overall change (CGI-I) by investigator and by the participants, non-habit forming property of the study product by evaluation of clinical symptoms (withdrawal) post stopping study product (10 Days after end of study intervention period), change in feeling of relaxation, calmness, deep sleep using on VAS, restless thoughts/racing thoughts before sleep, change in quality of life by assessing WHO-QOL**,** change in day time drowsiness, grogginess or brain fog on next day after product consumption (causality assessment), safety and tolerability of study products by assessing adverse events/ Adverse drug reactions and Laboratory related safety parameters on baseline visit, day 7, day 15,and day 30
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 aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent
- •Participants with score between 7-21 on ISI (Insomnia severity index)
- •Participants willing to sign inform consent form and ready to follow the study protocol requirements
- •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
- •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 & generalized anxiety disorder
- •Participants with history of drug or alcohol addiction or abuse within the past 12 months
- •Participants with habit of smoking Cigarette (Average of more than 5 cigarettes per day over the last 5 years)
- •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 shift work disorders and other psychiatric disorders which need medication
- •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/her participation in, and completion of the protocol.
结局指标
主要结局
1. Change in sleep parameters [Onset of sleep latency (SOL), Sleep Efficiency (SE), Total Bed time (TBT), Total Sleep Time (TST), Wake after Sleep Onset (WASO), Light Sleep, Deep Sleep, REM Sleep,] using Actigraphy
时间窗: Baseline visit, Day 7, Day 15, and Day 30
2. Change in sleep efficiency (Total sleep time/ Time in bed X 100) time of sleep onset, number of awakenings and wake time after sleep onset, (as per participant diary).
时间窗: Baseline visit, Day 7, Day 15, and Day 30
次要结局
- 1.Change in severity of sleep disturbance using Insomnia Severity Index(2 Change in daytime fatigue using Fatigue Severity Scale (FSS))
研究者
Dr Madhuri Rohidas Alhat
Nirvikar Ayurveda Hospital