None listed
Conditions
Interventions
Intervention1: EL STI 01 Tablet: Key ingredients of EL STI 01 Tablet are Melatonin, Valeriana wallichii extract, L-Tryptophan, L-Threonine, Magnesium, Nutmeg extract Dose: Participants will be
Sponsors
Emil Pharmaceutical Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in participant-reported total sleep 2.Change in stress on perceived stress scale Timepoint: Screening Visit Baseline visit, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Changes in sleep efficiency 3. Change in pre and post-serum cortisol (morning) levels 4. Change in quality of Life on the GHQ28 Scale 5. Change in participant-reported time to sleep onset 6. Change in severity of Insomnia using Insomnia Severity Index 7. Change in daytime fatigue using Fatigue Severity Scale (FSS) 8. Change in daytime mood, ability to function at work, concentration and memory 9. Change in quality of sleep on Pittsburgh Sleep Quality Index (PSQI) 10. Global assessment for overall change by investigator and by participant 11. Assessment of tolerability of study products 12. Pre and post- study product consumption laboratory investigations Timepoint: Screening Visit Baseline visit, Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed