Health Condition 1: G439- Migraine, unspecified Health Condition 2: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: MIGRAINE MASTER Mobile Application Guided Migraine Management: Participants will use the MIGRAINE MASTER mobile application to record migraine episodes, including frequency, duration,
if episodes or MIDAS scores do not improve, medication dose or step-up therapy will be adjusted according to protocol. Trigger identification and lifestyle advice will be provided through the app. No
Sponsors
saveetha medical college and hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1 .Age between eighteen and sixty five years 2.Diagnosis of migraine with or without aura according to ICHD three criteria confirmed by the investigator 3.Able and willing to provide written informed consent 4.Owns a smartphone using Android or iOS that is compatible with the Migraine Master app and is able to operate it, or has a caregiver who can operate it
Exclusion criteria
Exclusion criteria: 1.Medication overuse headache as defined by ICHD three for example regular analgesic opioid or triptan overuse 2.Other primary headache disorder as the predominant complaint for example cluster headache or chronic tension type headache that would confound outcomes 3. Change in migraine prophylactic medication within eight weeks prior to baseline or a planned change during the first twelve weeks of the study unless allowed under protocol step up rules 4.Use of an investigational drug or device within thirty days or within five half lives prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in MIDAS score from baseline to three months after using the Migraine Master mobile application and following the stepwise treatment protocol.Timepoint: at baseline and at three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in migraine episode frequency from baseline to three months. Change in migraine episode duration from baseline to three months. Change in migraine intensity from baseline to three months. Identification of migraine trigger patterns over the study period. Assessment of treatment response and need for step up therapy.Timepoint: Baseline and three months. | — |
Countries
India
Contacts
Public Contactmariraj i
saveetha medical college and hospital
Outcome results
None listed