Evaluation of efficacy of nutritional formula Sleepnite Tablet in patients suffering from Insomnia- A randomized placebo controlled clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- 3.Sleep efficiency (Total sleep time divided by time in bed multiplied by 100) derived from patient diary.
研究概览
简要总结
Prevalence of sleep disorder/deprivation is found to be alarming among the Indian population. COVID-19 pandemic has resulted in significant increase in insomnia. Insufficient sleep is considered to be a public health epidemic that is often unrecognized and under-reported. Burden of insomnia has been grossly underestimated. The effects of sleep disorders on the body are numerous and widely varied across multiple body systems. There are pharmacotherapies to aid in sleep but often are accompanied by huge adverse events. Recently there is lot of emphasize is to clinically validate the micronutrient and phytotherapy supplementation as a sustainable way of handling sleep disorders which are of mild to moderate severity and not secondary to any disease or disorder. In order to validate the hypothesis of usefulness of such interventions in primary insomnia, Sleepnite Tablet is a novel formula comprising herbal extracts and some assorted micronutrients, which are thought to be effective in management of insomnia and related symptoms.
The present research is an attempt of clinical validation of Sleepnite Tablet in patients suffering from insomnia. With the present research we can apply the knowledge from phytotherapy and nutrition along with the clinical trials to address important medical needs in insomnia patients to improve sleep. There is need to do primary translational work earliest & focus at some targeted aim and come up with a formulation for same to improve sleep quality and quantity, to improve daytime function, reduction of distress and changes associated with insomnia like fatigue, perceived stress, mood and cortisol levels. Which could be achieved through the present research. We can utilize these outcomes to develop a strategy for treating insomnia in more appropriate and assured way.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged greater than or equal to 18 and less than or equal to 65 years of both sex at the time of obtaining written informed consent;
- •Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR);
- •Insomnia Severity Index more than 7 and < 21 i.e. mild to moderate;
- •Patients with a diagnosis of Mild or moderate depression (Patients’ health questionnaire (PHQ-9) score of ≤14);
- •Patients with a diagnosis of Mild or moderate Generalized anxiety disorder (Generalized anxiety disorder (GAD) -7 questionnaire score of ≤10);
- •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;
- •No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial);
- •Willing to limit caffeine consumption while in the study.
排除标准
- •Difficulty sleeping due to a medical condition;
- •History of a neurological disorder;
- •Lifetime history of severe mental illness;
- •History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires sedating medication;
- •On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score ≥15 and GAD 7 score ≥11 scales);
- •History of substance abuse or dependence;
- •History or current evidence of a clinically significant cardiovascular disorder at pre study visit;
- •Taking certain prohibited medications;
- •Consumption of >15 cigarettes a day;
- •History of malignancy ≤5 years prior to signing informed consent;
- •Known hypersensitivity to any of the ingredients of Sleepnite tablet;
- •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
3.Sleep efficiency (Total sleep time divided by time in bed multiplied by 100) derived from patient diary.
时间窗: Screening, Day 30 and Day 60
1.Patient-reported total sleep time (as per patient diary).
时间窗: Screening, Day 30 and Day 60
2.Sleep latency (as per patient diary).
时间窗: Screening, Day 30 and Day 60
次要结局
- 1.Outcomes from patient diary (Patient-reported total sleep time, Patient- reported number of awakenings, Patient -reported wake time after sleep onset).(2.Severity of Insomnia using Insomnia Severity Index Scale.)