A Clinical study of a Sleep Support Supplement in improving Sleep Quality and reducing sleep problems

Phase 2

Not yet recruiting

Conditions: Sleep disorder, unspecified,

Registration Number: CTRI/2025/05/086650

Lead Sponsor: Dr Chetan H Savaliya

Brief Summary: This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a sleep Support Supplement (GPLIFE/PROD/2025/007) in improving sleep quality and alleviating symptoms associated with sleep disorders in adults. A total of 60 male and female participants, aged 21 to 50 years, diagnosed with mild to moderate insomnia and other symptoms related to sleep disorders, will be enrolled and randomized into either the test group (receiving the sleep care formula) or the placebo group. Each participant will undergo treatment for 30 days, with scheduled visits at screening, visit 1-baseline (day 1), visit 2- day 15 (±5 days), and visit 3- day 30 (±5 days). The primary endpoints include changes in Pittsburgh Sleep Quality Index (PSQI) scores and sleep diary outcomes such as total sleep time, sleep latency, number of awakenings, wake time after sleep onset, and sleep efficiency. Secondary measures include changes in Profile of Mood States (POMS-A), Insomnia Symptom Questionnaire (ISQ), and Perceived Stress Scale (PSS) scores. Additional assessments involve vital signs, clinical laboratory investigations (CBC, LFT, RFT), adverse event monitoring, and evaluation of treatment compliance and tolerability. Participants with significant medical or psychiatric conditions, recent use of sleep or stress-related therapies, substance abuse, or other confounding factors will be excluded. This study aims to generate clinical evidence supporting the safety and effectiveness of a natural sleep care formula as a standalone intervention for individuals experiencing sleep disturbances and stress-related symptoms.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Participants meeting all the following criteria will be eligible for the study: 1.Male and female participants aged 21 to 50 years (both inclusive); 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than and equals to 26; 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form; 4.Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM V TR); 5.Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate; 6.Participants with a diagnosis of mild or moderate depression (patients’ health questionnaire (PHQ 9) score of less than and equals to 14); 7.Participants with a diagnosis of mild or moderate generalized anxiety disorder (GAD) 7 questionnaire score of less than and equals to 10.

Exclusion Criteria

Participants meeting any of the following criteria will not be eligible for the study: 1.Difficulty sleeping due to a medical condition; 2.History of a neurological disorder; 3.History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication; 4.On going depression and generalized anxiety disorder (diagnosis on PHQ 9 score greater than and equals to 15 and GAD-7 score greater than and equals to 11 scales); 5.History of substance abuse or dependence; 6.History or current evidence of a clinically significant cardiovascular disorder at pre-study visit; 7.Taking certain prohibited medications; 8.Consumption of greater than 10 cigarettes a day; 9.current evidence or history of malignancy less than and equals to 5 years prior to signing informed consent; 10.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management; 11.Known hypersensitivity to any ingredients of product; 12.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 13.Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in Pittsburgh Sleep Quality Index (PSQI) score at screening and end of the study.	Screening, Visit 1, Visit 2 and Visit 3
2.Changes in outcomes from participant sleep diary (total sleep time, sleep latency, number of awakenings, wake time after sleep onset and sleep efficiency.	Screening, Visit 1, Visit 2 and Visit 3
3.Changes in Profile of Mood State abbreviated version (POMS A) score.	Screening, Visit 1, Visit 2 and Visit 3
4.Changes in Insomnia Symptom Questionnaire (ISQ) score.	Screening, Visit 1, Visit 2 and Visit 3

Secondary Outcome Measures

Name	Time	Method
1.Changes in perceived stress scale (PSS) score.	2.Safety parameters (CBC, LFT and RFT).

Trial Locations

Locations (1): Lokmanya Medical Research Centre and Hospital
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Research Centre and Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Ramshyam Agarwal
Principal investigator
8087282022
ramshyam.research@gmail.com