CTRI/2025/04/085087RecruitingNot Applicable
A Randomized, double-blind, placebo controlled, parallel group clinical study to evaluate the efficacy and safety of Melatonin Sustained Release (SR) Capsules (2 mg) in improving Sleep Parameters in healthy adults with poor sleep quality.
Nutriventia Limited2 sites in 1 country60 target enrollmentStarted: April 30, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Sleep efficiency as measured by polysomnography (PSG).
Study Overview
Brief Summary
60 subjects will be assigned in 1:1 ratio to treatment with the test product or Placebo in this double- blind, randomized, placebo- controlled, parallel study. All enrolled subjects will be instructed to take 1 capsules of Test or Placebo, daily at night 0.5-1.0 hours before bedtime. The efficacy of investigational product will be assessed by change in sleep parameters as measured by polysomnography between test and placebo groups. The other assessments included are Pittsburgh Sleep Quality Index (PSQI) global score, WHO-5 Wellbeing Index Quality of life and Sleep related parameters as per subject diary from baseline to Day 7, Day 14, Day 28. Safety will be assessed through Treatment Emergent Adverse events (AEs), frequency and severity (throughout the Study). Subject and Physician Global Assessment for treatment acceptability by Likert Scale will be done on Day 28.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and non-pregnant female adult subjects between 30 to 60 years of age and BMI 18.5 kg/m2 to 29.9 kg/m
- •Subjects having poor sleep quality as assessed by PSQI global Scores more than 5 on screening visit.
- •Subjects with a history of at least 3 episodes of sleep disturbances in the last month.
- •Willing to abstain from digital activity 3 hours prior to the PSG analysis.
- •Willing to maintain current dietary pattern, activity level, and stable body weight for the duration of the study, and refrain from any drastic lifestyle changes.
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
- •Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
- •Willing to participate in the 30 days study.
- •Willingness to undergo study procedures including polysomnography, blood tests, routine urine test and urine pregnancy test (UPT only for women of child bearing potential).
- •Willing to sign the informed consent and comply with study procedure.
Exclusion Criteria
- •Subjects younger than 30 and older than 60 years of age.
- •Subjects having lifestyle likely to interfere with sleep patterns including but not limited to.
- •shift-workers, subjects with jet lag, midnight shift or night shift workers).
- •Subjects with BMI more than equal to 30 kg/m
- •History of Diagnosis of any sleep disorders associated with a psychiatric disorder (for example, depression, anxiety, dementia), sleep disorders secondary to another medical condition (for example, sleep apnoea, circadian rhythm sleep disorder) or any chronic medical condition that is likely to be the cause of the sleep problem.
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •Post-menopausal female subjects on any Hormone Replacement Therapy.
- •Subjects taking insulin, psychotropics, anxiolytics, sedatives, hypnotics or herbal supplements or OTC product or multivitamins etc. for sleep or anxiety or any other psychological condition, or any other prescription product which has a known side effect of causing somnolence or sleep problems, within one month prior to the screening visit.
- •History of known allergy to investigational products.
- •History or presence of any clinically significant uncontrolled systemic disorder including but not limited to cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, urologic, pulmonary, dermatologic, renal and/or other major diseases.
- •Presence of controlled/ uncontrolled Diabetes Mellitus, Hypertension and Thyroid Disease and/or other diseases.
- •History or presence of alcohol intake (more than 2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) or addiction to nicotine (current smokers/tobacco users).
- •Exaggerated consumption of tea (more than equal to 500 ml per day), coffee (more than equal to 400 ml per day), or energy drink (more than equal to 250 ml per day).
- •Participation in any other trials involving investigational or marketed products within 3 months prior to the Screening Visit.
- •Any condition that in opinion of the Investigator, does not justify the Subjects’ participation in the study.
Outcomes
Primary Outcomes
Change in Sleep efficiency as measured by polysomnography (PSG).
Time Frame: Baseline to End of study
Secondary Outcomes
- 1. Change in sleep parameters assessed by PSG.(Baseline and End of study)
- 2. Change in Pittsburgh Sleep Quality Index (PSQI) global score, WHO-5 Wellbeing Index Quality of life and Sleep related parameters as per subject diary.(Baseline, Day 7, Day 14, End of Study)
- 3. Treatment Emergent Adverse events (AEs), frequency and severity.(Baseline to End of study)
- 4. Subject and Physician Global Assessment.(End of study)
Investigators
Study Sites (2)
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