Health Condition 1: G470- Insomnia
Conditions
Interventions
None listed
Sponsors
Ananta Hempworks Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provide informed consent prior to any study specific assessments being performed 2.Between 18 and 60 years old, inclusively 3.Insomnia as defined by an ISI score of 8 or above 4.Insomnia symptoms for at least 3 months or less than 6.5 hours of sleep per night 5. Resident of India and currently living in the India for the duration of the trial
Exclusion criteria
Exclusion criteria: 1. Presence of an active and progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) 2. Unstable medication regimen (change to schedule or dosage within the past 3 months) 3. Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction 4. Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am. 5. Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long- haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs. 6. Pregnant or planning to become pregnant during the course of the trial. 7. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias) 8. Participated in an investigational research study in the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Improvement in the Insomnia Severity Index (ISI) and sleep logs of insomnia patients at baseline and after 8 weeks Safety: â?¢ Adverse Events â?¢ Physical examination, including weight â?¢ Vital signs: blood pressure, heart rate, respiratory rate, body temperatureTimepoint: baseline & 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the duration of treatment effect after end of treatment. â?¢ To assess the safety and tolerability after 60 days repeated doses.Timepoint: baseline and 8 weeks | — |
Countries
India
Contacts
Public ContactDr Piyush Juneja
AyuQuo Herbals
Outcome results
None listed