Health Condition 1: Z733- Stress, not elsewhere classified Health Condition 2: G470- Insomnia
Conditions
Interventions
Intervention1: Hydron Alkaline Ionised Water (HAIW): Subject will be asked to consume HAIW as and even required for 30 days.
Control Intervention1: Packaged Drinking water: Subject will be asked to co
Sponsors
Hydron Alkaline Aqua Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female participants who perceive themselves to be under stress and also having insomnia 2. Participants willing to sign inform consent form 3. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
Exclusion criteria
Exclusion criteria: 1. History or diagnosis of another sleep disorder 2. Difficulty sleeping due to a medical condition 3. History of a neurological disorder 4. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication 5. On-going depression and generalized anxiety disorder 6. History of substance abuse or dependence 7. Taking certain prohibited medications (opium, cannabis (marijuana) and Methamphetamines) 8. Participants with habit of smoking Cigarette etc. 9. Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer 10. History of malignancy less than or equal to 5 years prior to signing informed consent 11. Known hypersensitivity to alkaline water or packaged drinking water 12. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in stress 2. Change in participant-reported total sleep time (as per participant diary) Timepoint: Baseline visit, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in sleep efficiency 2.Change in participant-reported time to sleep onset (as per participant diary) 3.Change in participant- reported number of awakenings (as per participant’s diary) 4. Change in participant -reported wake time after sleep onset 5. Change in daytime mood, ability to function at work, concentration and memory on a graded scale 6.Change in quality of Life 7.Change in fatigue as assessed on graded scale 8.Global assessment for overall change by investigator and by participants 9.Assessment of adverse events and vitalsTimepoint: Baseline visit, Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed