Clinical study on sleep tablets in sleep problem

Phase 2

Registration Number: CTRI/2024/03/063637

Lead Sponsor: SciTech Specialties Pvt. Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Participants having average (average of three night readings before baseline visit) sleep initiation greater than or equal to 30 minutes and effective sleep duration of less than or equal to 6 hours on Ballistocardiography

2. Participants diagnosed with insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR)

3. Insomnia Severity Index score more than 7 and less than or equal to 21

4. Participants willing to sign inform consent form and ready to follow the study protocol requirements

5. Female participants with reproductive potential with a negative pregnancy test (Urine) and agree to use contraception throughout study period

6. Participants willing to stop alcohol, caffeine, and nicotine consumption while in the study

Exclusion Criteria

Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator)

2.Participants with history of any neurological disorder causing interference in sleep

3.Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication

4.Participants with on going depression and generalized anxiety disorder treatment

5.Participants with history of substance abuse or dependence for the last 5 years

6.Participants taking certain prohibited medications like opium, cannabis (marijuana) and methamphetamines etc.

7.Participants with habit of smoking Cigarette etc. (More than 5 cigarettes per day)

8.Participants with known history of hepatitis B and or C

9.Participants with history of malignancy less than or equal to 5 years prior to study participation

10.Participants with known hypersensitivity to any of the ingredients of study products

11.Participants with 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
Change in sleep parameters (Time in bed, sleep initiation, effective sleep duration, Sleep continuity (Awakenings), tossing and turning, light sleep, NREM (non rapid eye movement) sleep, REM (rapid eye movement) sleep, Average Resting Breathing Rate (bpm), Max Resting Breathing Rate (bpm), Average Resting Heart Rate (bpm), Max Resting Heart Rate (bpm) using BallistocardiographyTimepoint: Screening Visit (up to 3 days), Day 0, Day 15 and Day 30

Secondary Outcome Measures

Name	Time	Method
1. Change in severity of Insomnia using Insomnia Severity Index <br/ ><br>2. Change in quality of sleep on Pittsburgh Sleep Quality Index <br/ ><br>3. Change in stress on perceived stress scale <br/ ><br>4. Change in daytime fatigue using Fatigue Severity Scale <br/ ><br>5. Change in daytime mood, ability to function at work, concentration, and memory on a graded scale <br/ ><br>6. Change in participant reported total sleep time (as per participant diary) <br/ ><br>7. Change in sleep efficiency, Time to sleep onset. Number of awakenings, Wake time after sleep onset based on participant diary <br/ ><br>8. Global assessment for overall change by investigator and by participant <br/ ><br>9. Assessment of tolerability of study products by assessing adverse events <br/ ><br>10. Assessment of Laboratory related safety investigations <br/ ><br>Timepoint: Screening Visit (up to 3 days), Day 0, Day 15 and Day 30