| CTRI Number |
CTRI/2023/10/058984 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Treatment patterns, patient characteristics, level of impairment and treatment outcomes in migraine |
|
Scientific Title of Study
|
Treatment patterns, patient characteristics, level of impairment and treatment outcomes in migraine: a single center cross sectional, prospective observational study and 3 month follow up |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Katragadda praveen kumar |
| Designation |
Senior resident |
| Affiliation |
Kasturba medical college ,manipal. |
| Address |
Department of neurology, kasturba medical college, tiger circle road, madhav nagar, eshwar nagar, manipal, karnataka.
Flat number 707, shambhavi habitat, vidyaratna nagar,manipal,karnataka.
576104
Udupi
KARNATAKA
576104
India |
| Phone |
9160309639 |
| Fax |
|
| Email |
prvn.katragadda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr arvind n prabhu |
| Designation |
Professor |
| Affiliation |
Kasturba medical college,manipal. |
| Address |
Department of neurology, kasturba medical college, tiger circle road, madhav nagar, eshwar nagar, manipal, karnataka.
Department of neurology, kasturba medical college, tiger circle road, madhav nagar, eshwar nagar, manipal, karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9448842945 |
| Fax |
|
| Email |
arvind.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr arvind n prabhu |
| Designation |
Professor |
| Affiliation |
Kasturba medical college ,manipal. |
| Address |
Department of neurology, kasturba medical college, tiger circle road, madhav nagar, eshwar nagar, manipal, karnataka.
Department of neurology, kasturba medical college, tiger circle road, madhav nagar, eshwar nagar, manipal, karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9448842945 |
| Fax |
|
| Email |
arvind.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, manipal. |
|
|
Primary Sponsor
|
| Name |
Katragadda praveen kumar |
| Address |
Department of neurology, kasturba medical college, tiger circle road, madhav nagar, eshwar nagar, manipal, 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 arvind n prabhu |
Kasturba medical college,manipal. |
Room no 11,department of neurology.
Udupi
KARNATAKA |
9448842945
arvind.prabhu@manipal.edu |
|
|
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: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients newly diagnosed with migraine: episodic or chronic migraine according to ichd-3 Criteria.
2. Patients who are diagnosed prior with migraine, but only on symptomatic or acute Treatment usage.
3. Patients who were diagnosed with migraine and who received prophylactic treatment Previously but discontinued since last 1 month.
4. All patients of either gender and age >18 years |
|
| ExclusionCriteria |
| Details |
1.Patient diagnosed with trigeminal cephalgia headache, cluster headache, secondary Headaches.
2.Patient not willing to give an informed written consent were excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess treatment patterns and outcomes of migraine at 3 month follow up with special focus on preventive medication treatment |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess clinical features, severity and level of impairment in migraine |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
20/10/2023 |
| 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 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
|
The migraine medications are ever expanding and various drugs either single or in combination are being used. The published papers continue to support the notion that migraine headache continues to be the most neglected, worst respected, poorly managed medical disorder in the world.The pattern, triggers and clinical features of migraine vary from place to place. Thus, we need to study the clinical profile, triggers of migraine and to look at the treatment pattern and response to the same.
This study is aimed to assess pattern, severity, clinical features of migraine, treatment patterns and treatment outcomes during 3 month follow up. |