A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with stress and insomnia
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Change in stress
研究概览
简要总结
It is a randomized, controlled, double blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with stress and insomnia. The study will be carried out at 3 to 4 centers in India. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking Water in 1:1 ratio. Subject will be asked to consume given water as and even required for 30 days. The primary objectives of the study will be to assess change in stress and participant-reported total sleep time (as per participant diary). The secondary objectives of the study will be to assess changes in sleep efficiency, change in participant-reported time to sleep onset (as per participant diary), change in participant- reported number of awakenings (as per participant’s diary), change in participant -reported wake time after sleep onset, change in daytime mood, ability to function at work, concentration and memory on a graded scale, change in quality of Life, change in fatigue as assessed on graded scale, global assessment for overall change by investigator and by participants and adverse events and vitals on baseline visit, day 15 and day 30
Results and Observations:
The study concludes that the use of HIAW showed a significant reduction in stress and improved sleep parameters like sleep efficiency and time to get sleep. Also, significant improvement was observed in daytime functioning and ability to work during the day with reduction in fatigue. Quality of life measured on WHO QOL showed better quality of life with HIAW as compared to PDW use with significant improvement in overall physical health. The use of HIAW was found to be safe without causing any adverse effects
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 61.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female participants who perceive themselves to be under stress and also having insomnia
- •Participants 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 another sleep disorder
- •History of a neurological disorder
- •History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
- •On-going depression and generalized anxiety disorder
- •History of substance abuse or dependence
- •Taking certain prohibited medications (opium, cannabis (marijuana) and Methamphetamines)
- •Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer
- •History of malignancy less than or equal to 5 years prior to signing informed consent
- •Known hypersensitivity to alkaline water or packaged drinking water
- •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 stress
时间窗: Baseline visit, Day 15, Day 30
2. Change in participant-reported total sleep time (as per participant diary)
时间窗: Baseline visit, Day 15, Day 30
次要结局
- 1.Changes in sleep efficiency(2.Change in participant-reported time to sleep onset (as per participant diary))
研究者
Dr Sandeep Shinde
Shivam Multispecialty & Accident Care Centre Pvt. Ltd