| CTRI Number |
CTRI/2025/04/083972 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mind the Gap: Missing Links in Childhood Migraine Treatment |
|
Scientific Title of Study
|
Characterizing gaps in the Pharmacologic Treatment of Childhood Migraine and its Association with Quality of Life: A Single-center Descriptive 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 Devendra Mishra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Paediatrics Department, Lok Nayak Hospital and Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604316 |
| Fax |
|
| Email |
drdmishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Mishra |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Paediatrics Department, Lok Nayak Hospital and Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968604316 |
| Fax |
|
| Email |
drdmishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarthak Joshi |
| Designation |
Medical Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Paediatrics Department,Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7351514210 |
| Fax |
|
| Email |
joshisarthak73n@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi(110002), India |
|
|
Primary Sponsor
|
| Name |
Sarthak Joshi |
| Address |
Room no. 4, OBH, MAMC, New Delhi(110002), India |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Sarthak Joshi |
Lok Nayak Hospital |
Paediatrics Department, Lok Nayak Hospital and Maulana Azad Medical College, Delhi
Central
DELHI |
7351514210
joshisarthak73n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Maulana Azad Medical College And Associated Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G43||Migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 6-12 years fulfilling the International Headache Society (ICHD-3)
diagnostic criterion for migraine |
|
| ExclusionCriteria |
| Details |
Mixed headache
Unable to read or understand either Hindi/English |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To document the current acute and preventive pharmacologic treatment in children
newly diagnosed with migraine. |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare these treatment practices with the standard treatment guidelines, to identify
the gaps in treatment. |
At baseline |
To analyze the association between the gaps in pharmacological treatment with the
quality of life of children with migraine. |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/04/2025 |
| 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="3"
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
|
We plan to analyze the current treatment practices in newly diagnosed
pediatric migraine patients using questionnaire method, compare them with the standard guidelines, and find the association between the treatment gaps and migraine severity. This may spur the pediatricians and neurologists in appropriately identifying and treating pediatric migraine |