| CTRI Number |
CTRI/2025/07/090648 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Efficacy and Safety Sleep Gummy versus Melatonin Monotherapy in Adults with Sleep Disorders- Randomized controlled study |
|
Scientific Title of Study
|
A Randomized, Open-Label Clinical Trial Comparing the Efficacy and Safety of Multi-Ingredient Sleep Gummy (Health Etc) versus Melatonin Monotherapy (Somelin 3mg) in Adults with Sleep Disorders: A 30-Day Comparative Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramasubramanian Chellamuthu |
| Designation |
Principle Investigator |
| Affiliation |
Ahana Hospitals LLP |
| Address |
Ahana Hospitals LLP,
Basement, Clinical Research Department,
No 7 subburaman street
Gandhi Nagar
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9843255444 |
| Fax |
|
| Email |
dr.ramasubramanian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramasubramanian Chellamuthu |
| Designation |
Principle Investigator |
| Affiliation |
Ahana Hospitals LLP |
| Address |
Ahana Hospitals LLP,
Basement, Clinical Research Department,
No 7 subburaman street
Gandhi Nagar
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9843255444 |
| Fax |
|
| Email |
dr.ramasubramanian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramasubramanian Chellamuthu |
| Designation |
Principle Investigator |
| Affiliation |
Ahana Hospitals LLP |
| Address |
Ahana Hospitals LLP,
Basement, Clinical Research Department,
No 7 subburaman street
Gandhi Nagar
Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9843255444 |
| Fax |
|
| Email |
dr.ramasubramanian@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ahana Hospitals LLP |
| Address |
Basement, Clinical Research Department,
No 7 subburaman street
Gandhi Nagar
Madurai-625020,Tamilnadu |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramasubramanian Chellamuthu |
Ahana Hospitals LLP |
Basement, Clinical Research Departmet,
No 7 subburaman street,
Gandhi Nagar,
Madurai
Madurai
TAMIL NADU |
9843255444
dr.ramasubramanian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Radianz Health Care and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Etc Sleep Gummy |
Valeriana wallichii extract -- 30 mg
Ashwagandha extract (Withania somnifera) -- 25 mg
L-Theanine -- 25 mg
Matricaria chamomilla aerial parts extract -- 15 mg
Passion flower (Passiflora foetida) extract -- 15 mg
Melatonin -- 3 mg
Saffron (Crocus sativus) extract -- 2 mg
Duration of Intervention- 30 days |
| Comparator Agent |
Somelin tablet |
Melatonin -- 3 mg
Duration of Intervention- 30 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Self-reported sleep difficulties ( less than or equal to 3 nights per week for at least 1 month)
Able to read and understand study materials
Willing to provide informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
Current diagnosis of severe psychiatric conditions requiring immediate intervention
Current use of prescription sleep medications
Shift workers with variable sleep schedules
Pregnant or nursing women
Known allergy or intolerance to melatonin or any component in the study products
Concurrent participation in another sleep intervention study
Unstable medical conditions that could interfere with sleep assessment |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Between-group comparison of change in Pittsburgh Sleep Quality Index (PSQI) from baseline to 1 month |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Between-group comparison of Insomnia Severity Index (ISI) changes
Between-group comparison of Patient Global Impression of Change (PGIC) for sleep quality
Comparative analysis of adverse events and side effects between groups
Treatment satisfaction comparison |
1 month |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This one-month randomized, open-label, comparative assessment aims to evaluate and compare the effects of melatonin-based sleep gummy supplements versus standard melatonin therapy on sleep quality in adults aged 40-70 experiencing sleep difficulties. Using validated public domain sleep assessment tools including the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI), the study will track changes in sleep parameters through scheduled assessments at baseline, mid-point (day 15), and study conclusion (day 30). The two-arm, parallel-group design will randomize 150 participants who meet specific eligibility criteria into two treatment groups: Group A receiving standardized Health Etc sleep gummies containing multiple active ingredients including melatonin 3mg, and Group B receiving Somelin (Melatonin 3mg) tablets. Both groups will be followed through three clinic visits over 30 days. Primary outcomes focus on comparative changes in PSQI scores between groups, while secondary outcomes include comparative insomnia severity reduction, quality of life improvements, and participant satisfaction. This protocol employs publicly available assessment tools without copyright restrictions and includes comprehensive eligibility screening to ensure appropriate participant selection. |