Clinical study on EL STI 01 in stress and insomnia
- Registration Number
- CTRI/2024/01/061052
- Lead Sponsor
- Emil Pharmaceutical Industries Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy Participants who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS)
2. Healthy Participants having insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-5)
3.Insomnia Severity Index more than 7 and greater than 21
4. Participants willing to sign inform consent form
5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
1.History or diagnosis of another sleep disorder
2.Difficulty sleeping due to a medical condition
3.History of a neurological disorder
4.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
5.On going depression and generalized anxiety disorder
6.History of substance abuse or dependence
7. Taking certain prohibited medications [opium, cannabis (marijuana) and methamphetamines]
8.Participants with habit of smoking Cigarette etc.
9.Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer
10.History of malignancy less than or equal to 5 years prior to signing informed consent
11.Known hypersensitivity to any of the ingredients of study products
12.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in participant-reported total sleep <br/ ><br>2.Change in stress on perceived stress scale <br/ ><br>Timepoint: Screening Visit Baseline visit, Day 15, Day 30
- Secondary Outcome Measures
Name Time Method 2.Changes in sleep efficiency <br/ ><br>3.Change in pre and post-serum cortisol (morning) levels <br/ ><br>4.Change in quality of Life on the GHQ28 Scale <br/ ><br>5.Change in participant-reported time to sleep onset <br/ ><br>6.Change in severity of Insomnia using Insomnia Severity Index <br/ ><br>7.Change in daytime fatigue using Fatigue Severity Scale (FSS) <br/ ><br>8.Change in daytime mood, ability to function at work, concentration and memory <br/ ><br>9.Change in quality of sleep on Pittsburgh Sleep Quality Index (PSQI) <br/ ><br>10.Global assessment for overall change by investigator and by participant <br/ ><br>11.Assessment of tolerability of study products <br/ ><br>12.Pre and post- study product consumption laboratory investigations <br/ ><br>Timepoint: Screening Visit Baseline visit, Day 15, Day 30