| 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
|
|
|
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
|
|
|
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. |