| CTRI Number |
CTRI/2025/12/099183 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Different treatments for prevents migraine headaches. |
|
Scientific Title of Study
|
Randomized Comparative Trial of Flunarizine Vs Magnesium in the Prophylaxis of Migraine attacks. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSmitha Chandra B C |
| Designation |
Professor |
| Affiliation |
PESU Institute of medical sciences and research |
| Address |
Room No 2 Department of ENT PESUIMSR Konappana agrahara Electronic city
Bangalore
KARNATAKA
560100
India |
| Phone |
7259511715 |
| Fax |
|
| Email |
Smitha.bc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSmitha Chandra B C |
| Designation |
Professor |
| Affiliation |
PESU Institute of medical sciences and research |
| Address |
Room No 2 Department of ENT PESUIMSR Konappana agrahara Electronic city
KARNATAKA
560100
India |
| Phone |
7259511715 |
| Fax |
|
| Email |
Smitha.bc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSmitha Chandra B C |
| Designation |
Professor |
| Affiliation |
PESU Institute of medical sciences and research |
| Address |
Room No 2 Department of ENT PESUIMSR Konappana agrahara Electronic city
KARNATAKA
560100
India |
| Phone |
7259511715 |
| Fax |
|
| Email |
Smitha.bc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PES University Institute of Medical Sciences and Research |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [No sponsor ] |
|
|
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 Smitha Chandra B C |
PES University Institute of Medical Sciences and Research |
Department of ENT, Room No: 2, 2nd Floor, PES University EC campus, Hosur road, Konappana agrahara, Bengaluru 560100
Bangalore
KARNATAKA |
7259511715
Smitha.bc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PES University Institute of Medical sciences and Research-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Flunarizine |
This is a drug available in tablet form.
Dose-10mg
Frequency-once a day (Night)
Duration of treatment-3 months |
| Intervention |
Magnesium oxide |
This is a nutraceutical available in tablet form.
Dose-400mg
Frequency-once a day (Morning)
Duration of treatment-3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with migraine without aura according to the diagnostic criteria specified by ICHD-3 (International classification of headache disorders)
Patients having no abnormal findings on systemic and neurological examination.
Having more than 3 migraine attacks per month.
Not having taken any prophylactic medicines for migraine in the last 4 months
Patients who provide consent
|
|
| ExclusionCriteria |
| Details |
Suffering from heart, liver, and renal diseases.
A blood pressure over 180/95 mm of Hg, pregnancy or lactation.
Usage of alcohol and drug abuse.
Patients not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy and safety of flunarizine and magnesium oxide in reducing migraine frequency and severity. |
Follow up is scheduled at 2 weeks, 4 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the change in migraine related disability |
12 weeks (Disability assessed at baseline that is 0th week) |
| To assess the use of analgesics during migraine attacks |
12 weeks (Use of analgesics will be assessed at follow up during 2 weeks, 4 weeks and 12 weeks) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
19/01/2026 |
| 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
|
Migraine is a neurological disorders characterized by recurrent episodes of severe, unilateral headaches often accompanied by nausea, vomiting, photophobia and phonophobia. In India prevalence of migraine is approximately 25 percent which is greater than the global average. Flunarizine is a calcium channel blocker ,has been extensively studied and proven effective for preventing migraine. Recent studies have also shown promising results for magnesium in migraine prophylaxis. This study seeks to bridge the knowledge gap in migraine prophylaxis by directly comparing the efficacy, safety, and tolerability of flunarizine and magnesium in Indian population, where limited region specific-evidence currently exists, thereby informing clinical decision making and optimizing treatment outcomes. |