| CTRI Number |
CTRI/2025/12/099220 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Clinical profile and quality of life in children and adolescents with migraine |
|
Scientific Title of Study
|
Clinical profile and quality of life in children aged 5 to 18 years with migraine |
| 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 Swarnalekha Maddula |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Paediatrics ,Kasturba Medical college, Madhav Nagar, Manipal 576104, Udupi , Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
09676883388 |
| Fax |
|
| Email |
swarnalekhamaddula3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikiran A Hebbar |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics ,Kasturba Medical college, Madhav Nagar, Manipal 576104, Udupi , Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448177671 |
| Fax |
|
| Email |
shrikiran.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrikiran A Hebbar |
| Designation |
Professor and Head of unit |
| Affiliation |
Kasturba medical college |
| Address |
Department of Paediatrics ,Kasturba Medical college, Madhav Nagar, Manipal 576104, Udupi , Karnataka
KARNATAKA
576104
India |
| Phone |
9448177671 |
| Fax |
|
| Email |
shrikiran.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and hospital Madhav nagar Manipal 576104 Udupi Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Shrikiran A Hebbar |
| Address |
Department of Paediatrics ,Kasturba Medical college, Madhav Nagar, Manipal 576104, Udupi , Karnataka
Department of Paediatrics ,Kasturba Medical college, Madhav Nagar, Manipal 576104, Udupi , Karnataka |
| Type of Sponsor |
Other [self] |
|
|
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 Swarnalekha Maddula |
Kasturba medical college ,Manipal |
Department of Paediatrics
Udupi
KARNATAKA |
9676883388
swarnalekhamaddula3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional ethics committee |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children and adolescents aged 5 to 18 years diagnosed with migraine according to international classification of headache disorders criteria. |
|
| ExclusionCriteria |
| Details |
1) children with secondary headaches
2) patients with pre existing neurological disorders
3)children on long term medications known to cause headaches as side effects unless evaluated separately.
4) children with hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the clinical profile and quality of life in children aged 5 to 18 years with migraine diagnosed as per ICHD 3 guidelines |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Migraine is one of the most common primary headache disorders in children and adolescents, with a significant impact on their quality of life, academic performance, and psychosocial well-being. Despite its high prevalence, it often remains underdiagnosed or misdiagnosed in Paediatrics populations due to atypical presentations and overlap with other conditions. Moreover, children with migraine frequently suffer from comorbidities such as anxiety, depression ,poor school performance ,obesity, epilepsy and sleep disorders, which can complicate diagnosis and management. This study is a prospective observational study with the aim of studying clinical profile 5 to 18 years with migraine diagnosed according to International classification of headache disorders - 3rd edition criteria and in addition assessing their quality of life based on PedMidas questionnaire .Findings in this study may help strengthen clinical practice by timely interventions and preventing comorbidities for children at risk. |