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CTRI Number  CTRI/2025/04/085087 [Registered on: 17/04/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To check the effect and safety of Melatonin capsule (2 mg) in improving sleep in healthy adults with poor sleep quality. 
Scientific Title of Study   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.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NV-MelSR-CT01-25   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milind Kulkarni 
Designation  Principal Investigator 
Affiliation  Kulkarni Clinic 
Address  Office No.7, First Floor, Guru Krupa Apartment, Tingre Nagar Rd, Kasturba C, Kasturba Housing Society, Vishrantwadi, Pune, Maharashtra 411015

Pune
MAHARASHTRA
411015
India 
Phone  9860312537  
Fax    
Email  drmilindjivi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sornaraja Thasma  
Designation  Director Quality Assurance  
Affiliation  ProRelix Services LLP 
Address  102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune Maharashtra.

Pune
MAHARASHTRA
411052
India 
Phone  8124806366  
Fax    
Email  s.thasma@prorelixresearch.com  
 
Details of Contact Person
Public Query  
Name  Mrs Aditi Vaidya  
Designation  Senior Manager 
Affiliation  ProRelix Services LLP 
Address  102 A/B, Park Plaza, Main Karve Nagar Chowk, Karve Nagar, Pune Maharashtra.

Pune
MAHARASHTRA
411052
India 
Phone  8602571013  
Fax    
Email  a.vaidya@prorelixresearch.com  
 
Source of Monetary or Material Support  
Nutriventia Limited, Unit 703 and 704, 7th Floor Solaris One Premises Cooperative Society Limited, N.S. Phadke Marg, Andheri(East), Mumbai- 400069, India 
 
Primary Sponsor  
Name  Nutriventia Limited 
Address  Unit 703 & 704, 7th Floor Solaris One Premises Co operative Society Limited, N.S. Phadke Marg, Andheri (East), Mumbai - 400 069.  
Type of Sponsor  Other [Nutraceutical Industry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat Jain  Dhanwantari Hospital  1st Floor, Clinical research department, 339-c, Mudaliar Rd, next to Kaka Halwai, Rasta Peth, Pune, Maharashtra - 411002, India.
Pune
MAHARASHTRA 		 9860383386

dr_bharatjain@rediffmail.com 
Dr Milind Kulkarni  Kulkarni Clinic  Office No. 7, First Floor, Guru Krupa apartment, Tingre Nagar Rd, Kasturba C, Kasturba Housing Society, Vishrantwadi, Pune, Maharashtra 411015
Pune
MAHARASHTRA 		 9860312537

drmilindjivi@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Central Independent Ethics Committee  Approved 
Jivanrekha Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy adults with poor sleep quality 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Melotime Capsules  Melatonin Sustained Release (SR) 2 mg Melatonin. 1 capsule at night 0.5-1.0 hours before bedtime for the duration of 28 days. 
Comparator Agent  Placebo capsules  Placebo capsule (Identical to intervention but without any active ingredient). 1 capsule at night 0.5-1.0 hours before bedtime for the duration of 28 days. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and non-pregnant female adult subjects between 30 to 60 years of age and BMI 18.5 kg/m2 to 29.9 kg/m2.
2. Subjects having poor sleep quality as assessed by PSQI global Scores more than 5 on screening visit.
3. Subjects with a history of at least 3 episodes of sleep disturbances in the last month.
4. Willing to abstain from digital activity 3 hours prior to the PSG analysis.
5. 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.
6. 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.
7. Results of screening procedures and lab investigations are within normal range or considered not clinically significant by the Principal Investigator.
8. Willing to participate in the 30 days study.
9. Willingness to undergo study procedures including polysomnography, blood tests, routine urine test and urine pregnancy test (UPT only for women of child bearing potential).
10. Willing to sign the informed consent and comply with study procedure. 
 
ExclusionCriteria 
Details  1. Subjects younger than 30 and older than 60 years of age.
2. 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).
3. Subjects with BMI more than equal to 30 kg/m2.
4. 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.
5. Female subjects, who are pregnant, breast feeding or planning to become pregnant.
6. Post-menopausal female subjects on any Hormone Replacement Therapy.
7. 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.
8. History of known allergy to investigational products.
9. 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.
10. Presence of controlled/ uncontrolled Diabetes Mellitus, Hypertension and Thyroid Disease and/or other diseases.
11. 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).
12. 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).
13. Participation in any other trials involving investigational or marketed products within 3 months prior to the Screening Visit.
14. Any condition that in opinion of the Investigator, does not justify the Subjects’ participation in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Sleep efficiency as measured by polysomnography (PSG).  Baseline to End of study 
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.  
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