Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Power therapeutic water: 1 Glass of Power therapeutic
water (330 mL) in the morning
immediately after waking up and
1 Glass of water at least 1 hour
after dinner.
Control Intervention1:
Sponsors
Mystic Kingdom Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants meeting all the following criteria will be eligible for the study: 1. Male and female participants aged 18-50 years (both inclusive). 2. Suffering from self-reported mild to moderate stress on PSS scale score less than or equal to 26. 3. Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate. 4. Patients with a diagnosis of Mild or moderate depression (Patients health questionnaire (PHQ-9) score of less than or equal to 14). 5. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period. 6. 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 consent not to use the same during the period of the trial). 7. Willing to limit caffeine consumption while in the study. 8. Participants willing to participate in the study and comply with its procedures by signing a written informed consent.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will not be eligible for the study: 1. Difficulty sleeping due to a medical condition. 2. History of a neurological disorder. 3. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication. 4. On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score greater than or equal to 15 and GAD-7 score greater than or equal to 11 scales). 5. History or current heavy alcohol consumption or substance abuse or dependence. 6. History or current evidence of a clinically significant cardiovascular disorder at pre-study visit. 7. Taking certain prohibited medications. 8. Consumption of greater than 10 cigarettes a day. 9. Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to completely restrict their intake throughout the study. 10. History of malignancy less than or equal to 5 years prior to signing informed consent and current evidence of cancer. 11. Known hypersensitivity to any ingredients of product. 12. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management. 13. Females who are pregnant and have a positive urine pregnancy test or planning to be pregnant or lactating or not using reliable methods of contraception. 14. Participation in any other clinical study within the past 3 months or ongoing. 15. Any other reason that, in the opinion of the investigator, excludes the participant from eligibility for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in insomnia severity index (ISI) score 2. Changes in outcomes from participant sleep diary (total sleep time, sleep latency, number of awakenings, wake time after sleep onset, sleep efficiency (Total sleep time or time in bed into 100) 3. Changes in perceived stress scale 10 (PSS-10) score 4. Changes in Patients health questionnaire (PHQ-9) score 5. Changes in muscle strength through handgrip strength using a hand-held dynamometer deviceTimepoint: 1. screening, week 2, week 4, and week 6 2. baseline to week 6 3. screening, week 2, week 4, and week 6 4. screening, week 2, week 4, and week 6 5. screening and week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in vital signs throughout the study. 2. Adverse events profile 3. Compliance and tolerability of the investigational productTimepoint: 1. Screening to Week 6 2. Baseline to Week 6 3. Week 2, week 4, Week 6 | — |
Countries
India
Contacts
Public ContactMs Anamika Kapur
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed