Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: Sleep well capsules: Sleep/ Well is a herbal formula that consist of the following crude herbs: Valeriana Wallichi, Passiflora Incarnata, Ziziphus spinose, Melatonin, Glutamine.
Control
Sponsors
MOOM HEALTH PTE LTD
Spectrum Clinical Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female participants with Age between 25-40 years. 2. Females facing problems while initiating or maintaining sleep. 3. Willing to participate in the study after informed consent. 4. Pittsburgh Sleep Quality Instrument score higher than 5
Exclusion criteria
Exclusion criteria: 1. Current use of prescribed or over-the-counter sleep medications. 2. Pregnant or lactating mother. 3. Current unusual or highly unstable sleep schedule 4. Trans-meridian travel across more than three time zones within 4 weeks prior to study entry. 5. Significant and uncontrolled major illness or psychiatric disease 6. Current life stress. 7. Use of tobacco within 6 months prior to study entry 8. Excessive use of alcohol or caffeine. 9. Currently taking hormone replacement therapy hypnotic or psychotropic medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in sleep latency. Improvement in sleep qualityTimepoint: Visit 1 visit 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in sleep qualityTimepoint: Visit 1 visit 2 | — |
Countries
India
Contacts
Public ContactDr Viral Shah
Spectrum Clinical Research Pvt Ltd
Outcome results
None listed