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CTRI Number  CTRI/2025/11/097672 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [transdermal patch ]  
Study Design  Single Arm Study 
Public Title of Study   A Gentle Cream with Mother’s Touch to Help Special Children Sleep Peacefully 
Scientific Title of Study   MMT cream for sleep induction in children with special needs (Mothers Melatonin touch ) 
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 Akshai 
Designation  PG student 
Affiliation  Saveetha medical college hospital 
Address  Ward no.120, 1st floor,paediatric ward,Department of paediatrics, saveetha medical college hospital building
Ward no.120, 1st floor,paediatric ward,Department of paediatrics, saveetha medical college hospital building
Chennai
TAMIL NADU
602105
India 
Phone  8939694425  
Fax    
Email  akshaisrk1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lal Devayanivasudevan Nair 
Designation  Professor 
Affiliation  Saveetha medical college hospital 
Address  Room no. 124, 1st floor, Paediatric ward, Department of paediatrics,162, Saveetha nagar, poonammalle high road, thandalam, chennai
Room no. 124, 1st floor, Paediatric ward, Department of paediatrics,162, Saveetha nagar, poonammalle high road, thandalam, chennai
Chennai
TAMIL NADU
602105
India 
Phone  7299938038  
Fax    
Email  drlaldv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Akshai 
Designation  PG student 
Affiliation  Saveetha medical college hospital 
Address  Ward no.120, 1st floor,paediatric ward,Department of paediatrics, saveetha medical college hospital building
Ward no.120, 1st floor,paediatric ward,Department of paediatrics, saveetha medical college hospital building
Chennai
TAMIL NADU
602105
India 
Phone  8939694425  
Fax    
Email  akshaisrk1@gmail.com  
 
Source of Monetary or Material Support  
Saveetha Medical college hospital,162, saveetha nagar,poonamallee high road,thandalam, chennai-602105 
 
Primary Sponsor  
Name  Saveetha medical college hospital 
Address  162, saveetha nagar, poonammalle high road, thandalam, chennai-602105 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Lal  Saveetha medical college hospital  ward no.120, 1st floor , paediatric ward, department of paediatrics,162, saveetha nagar, poonamallee high road, thandalam, chennai-602105
Chennai
TAMIL NADU 
7299938038

drlaldv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F99||Mental disorder, not otherwise specified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  application of melatonin cream   applying melatonin cream in children for sleep induction , thrice a day for duration of 8 weeks  
Comparator Agent  nil  nil  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  children aged between 3 to 10 years admitted in our hospital with neurodevelopmental disorders 
 
ExclusionCriteria 
Details  those not providing consent for participation in our study 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Melatonin cream induces sleep in special children   baseline,4 week, 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   Phase 3 
Date of First Enrollment (India)   19/11/2025 
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="1"
Months="0"
Days="0" 
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  

Many children with autism, ADHD, or cerebral palsy struggle to fall asleep, which affects their mood, learning, and family well-being. Current sleep medicines like oral melatonin can be hard to swallow, have variable absorption, or cause fear of dependency. To solve this, we developed MMT Cream (Mother’s Melatonin Touch)—a gentle transdermal cream with 1 mg melatonin per gram, combined with soothing scents like lavender or vanilla. It is applied on the child’s chest, wrist, or feet during bedtime, allowing both calming touch and hormonal sleep support at the same time.This pilot study will include 15–20 children aged 3–10 years. For 2 weeks, we will observe their normal sleep (baseline), then give the cream daily for 4 weeks. Sleep onset time, total sleep, night awakenings, and parent satisfaction will be measured using actigraphy, sleep questionnaires, and diaries.

 
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