Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Health Etc Sleep Gummy: Valeriana wallichii extract -- 30 mg
Ashwagandha extract (Withania somnifera) -- 25 mg
L-Theanine -- 25 mg
Matricaria chamomilla aerial parts extract -- 15 mg
Pa
Sponsors
Ahana Hospitals LLP
Eligibility
Inclusion criteria
Inclusion criteria: Self-reported sleep difficulties ( less than or equal to 3 nights per week for at least 1 month) Able to read and understand study materials Willing to provide informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: Current diagnosis of severe psychiatric conditions requiring immediate intervention Current use of prescription sleep medications Shift workers with variable sleep schedules Pregnant or nursing women Known allergy or intolerance to melatonin or any component in the study products Concurrent participation in another sleep intervention study Unstable medical conditions that could interfere with sleep assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Between-group comparison of change in Pittsburgh Sleep Quality Index (PSQI) from baseline to 1 monthTimepoint: 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group comparison of Insomnia Severity Index (ISI) changes Between-group comparison of Patient Global Impression of Change (PGIC) for sleep quality Comparative analysis of adverse events and side effects between groups Treatment satisfaction comparisonTimepoint: 1 month | — |
Countries
India
Contacts
Public ContactDr Ramasubramanian Chellamuthu
Ahana Hospitals LLP
Outcome results
None listed