Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Conditions
Interventions
Intervention1: SLEPOVIN: 500mg capsule to be taken orally, once daily for 30 days
Control Intervention1: Placebo: 500mg capsule to be taken orally once daily for 30 days
Sponsors
BigBrother Nutra Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged above 18 years old (inclusive) 2. Subject is in good physical status and mental health 3. Male or female subjects aged above 18 years old (inclusive) 4.Subject is in good physical status and mental health 5. Sleep onset insomnia (difficulty taking sleep at the beginning of the night) 6. Sleep maintenance insomnia (difficulty in maintaining the sleep) 7. Nocturnal awakenings, difficulty in retuning to sleep after awakening in the middle of the night or wakening early in the morning 8. Insomnia severity index > 7 9. Subject is willing to limit alcohol, caffeine, and nicotine consumption while in the study 10. Habitual bedtime between 8.30 pm and midnight 11. Able and willing to follow all study related instructions and to complete all required visits 12. Subjects willing to give inform consent for participation
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness (es) 2. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires a prohibited medication 3. Subjects who suffer from sleep disorder other than primary insomnia including restless leg syndrome and sleep apnea 4. Subjects with substance dependence/ abuse in the past one year or with alcohol abuse are ineligible 5. Subjects taking certain prohibited medications 6. Females who are pregnant, lactating or likely to become pregnant during the study 7. Subjects using tobacco products or caffeinated beverages during night awakenings. 8. Clinical history of allergy/ hypersensitivity to one or more products of herbal origin. Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 3 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Mean change in Subjective Sleep Onset Latency (sSOL) (Time frame: Beginning of placebo-controlled treatment 1 month of placebo-controlled treatment. â?¢ Mean change in Subjective Sleep Efficiency (sSE) â?¢ Mean change in sSOL, sWASO, and Subjective Total Sleep Time (sTST) Timepoint: Day 0 Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in Insomnia Severity Index from baseline to end of visit â?¢ Changes in Epworth Sleepiness Scale from baseline to end of visit â?¢ Monitor any adverse event on (Day 15±1) and Day30±2Timepoint: Day 0 Day 30 | — |
Countries
India
Contacts
Public ContactDivya C
Bio Agile Therapeutics Pvt. Ltd.
Outcome results
None listed