Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company (HWC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants with a) difficulty in initiating sleep, b) staying asleep or waking up early in the morning c) for at least for 3 nights per week d) for at least last 1 month and e) Insomnia with significant distress and persistent preoccupation with deficiency of sleep 2. Subjects 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 any other physical, psychological or psychosomatic (including neurological) sleep disorder 2. Subjects with ongoing medications that may be considered contributory to insomnia like psychostimulants, amphetamines, cold medicines, decongestants (like oxymetazoline), beta-agonist, theophylline, caffeine, and any other as determined by the investigator. 3. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids like prednisone, opioid pain relievers, hypnotics and or prescribed other regular sleep medication. 4. History of bipolar disorder, psychotic disorder including depression and generalized anxiety disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication 5. History of substance abuse or dependence 6. Subjects with habit of smoking Cigarette (more than 10 cigarette per day) 7. Subjects with known history of Hepatitis B and or C 8. History of malignancy less than or 5 years prior to signing informed consent 9. Known hypersensitivity to any of the ingredients (Tagara etc.) of study product 10. Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Change in sleep parameters (Total sleep time, Light sleep, Deep Sleep, REM sleep, No. of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Average resting heart rate, Average resting respiration rate through Actigraphy 2)Change in Sleep parameters (Total sleep time, no of awakenings, Total duration of awakenings (WASO), Sleep efficiency, Time to get up after wake up, overall Sleep Quality) through sleep diary Timepoint: Screening Visit/ Baseline visit (intervention free period), Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in stress as assessed using Stress Mindset Measure (SMM) 2. Change in insomnia-related daytime functioning (daytime sleepiness, tiredness, mood disturbances, irritability) on graded scale in natural setting 3. Change in fatigue on VAS 4. Global assessment for overall change by investigator and by subject 5. Assessment of tolerability of study product by assessing adverse events and Adverse drug reactions 6. Safety of study product through clinical & laboratory assessment (Hematology (CBC), SGOT, Sr. Creatinine, Blood Sugar). 7. Safety evaluation through assessment of adverse events 8. Proportion of subjects withdrawing from the study because of adverse events (tolerability). Timepoint: Screening Visit/ Baseline visit (intervention free period), Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Himalaya Wellness Company
Outcome results
None listed