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CTRI Number  CTRI/2020/12/030019 [Registered on: 24/12/2020] Trial Registered Prospectively
Last Modified On: 23/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Melsoma in Pediatric ADHD Patients 
Scientific Title of Study   Safety and Efficacy of Melsoma Nano Spray for Treating Sleep Disturbances in Children with ADHD 
Trial Acronym  MELSOMA IN ADHD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mona P Gajre 
Designation  Professor, Department of Pediatrics 
Affiliation  LTMMC AND LTMGH 
Address  Department of Pediatrics LTMMC AND LTMGH, Sion Mumbai

Mumbai
MAHARASHTRA
400 022
India 
Phone  9820407240  
Fax    
Email  monapote@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Mona P Gajre 
Designation  Professor, Department of Pediatrics 
Affiliation  LTMMC AND LTMGH 
Address  Department of Pediatrics LTMMC AND LTMGH, Sion Mumbai


MAHARASHTRA
400 022
India 
Phone  9820407240  
Fax    
Email  monapote@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Mona P Gajre 
Designation  Professor, Department of Pediatrics 
Affiliation  LTMMC AND LTMGH 
Address  Department of Pediatrics LTMMC AND LTMGH, Sion Mumbai


MAHARASHTRA
400 022
India 
Phone  9820407240  
Fax    
Email  monapote@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr.Harsh Chaturvedi, Pulse Pharmaceuticals Pvt. Ltd Plot No. 18/1, Sector-III, HUDA Techno Enclave, HITEC City, Hyderabad, Telangana 500081 
 
Primary Sponsor  
Name  Pulse Pharmaceuticals Pvt Ltd 
Address  Plot No. 18/1, Sector-III, HUDA Techno Enclave, HITEC City, Hyderabad, Telangana 500081 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Mona P Gajre  Lokmanya Tilak Municipal General Hospital And Medical College,Sion, Sion  Department of Pediatrics Lokmanya Tilak Municipal General Hospital And Medical College, Sion Mumbai 400 022
Mumbai
MAHARASHTRA 		 9820407240

monapote@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH LOKMANYA TILAK MUNCIPALITY MEDICAL COLLEGE AND GENERAL HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Melsoma Nano Spray   Melsoma Nano Spray should be Sprayed (2-3 sprays under tongue daily at night) 30 - 60 minutes before going to bed. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children who meet DSM-5 criteria for ADHD.
2.ADHD patients with the complaints of sleep disorder.
3.Patients who are not on any sedating drugs and having complaints of sleep disturbances.
4.Willingness and able to give informed consent, and comply with requirements for participation in the study
 
 
ExclusionCriteria 
Details  1.Children with other psychiatry and medical illness will not be included. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the changes in the severity of insomnia by using Insomnia Severity Index (ISI) scale.  6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
To document any adverse events associated with the use of Melsoma Nano Spray  6 MONTHS 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   25/12/2020 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included ctri.nic.in).

  6. For how long will this data be available start date provided 23-06-2021 and end date provided 23-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim:

1)      To study prevalence and type of sleep disturbances in children with ADHD

2)       To study safety and efficacy of Melsoma Nano Spray in treating sleep disturbances in children with ADHD

Primary objective:

 To determine the changes in the severity of insomnia by using Insomnia Severity Index (ISI) scale.

Secondary objective:

 To document any adverse events associated with the use of Melsoma Nano Spray

Study Site:


Out-patient departments of Pediatrics and Psychiatry of LTMMC and LTMGH, Sion, Mumbai.

Duration of Study:

Approximately 6 Months.

Study Description:

Design:

Single Centre, Open label, Prospective, Interventional, & Active Post-Marketing Surveillance study

Sample Size:

Sixty (60) patients will be recruited in the study

Sample Method:

All patients fulfilling inclusion criteria will be included in the study

Study Population:

·         Inclusion Criteria:

1.      Children who meet DSM-5 criteria for ADHD.

2.      ADHD patients with the complaints of sleep disorder.

3.      Patients who are not on any sedating drugs and having complaints of sleep disturbances.

4.      Willingness and able to give informed consent, and comply with requirements for participation in the study.

   Exclusion criteria:

1.    Children with other psychiatry and medical illness will not be included.


 
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