Health Condition 1: G431- Migraine with aura Health Condition 2: G430- Migraine without aura
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with migraine accompanied by light and sound sensitivity as well as nausea as per International Classification of Headache Disorders, 3rd Edition (ICHD-3). 2. Subjects who are ready to sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are not ready to sign the informed consent. 2. Subjects with major systemic diseases such as malignancy, connective tissue disorders, liver, and renal diseases, or any other illness which according to the investigator forbids him/her from participating in this clinical trial. 3. Subjects who are already receiving migraine therapy or have taken migraine therapy in the last 15 days from the date of screening. 4. Subjects who have participated in any clinical study in less than a month before the screening visit. 5. Pregnant or breast-feeding female subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To compare the total number of migraine days between two groups over the treatment period. 2. To compare the reduction in frequency of migraine attacks. Timepoint: Day 0 (Baseline),Day15 (2 weeks),Day30,Day60,Day90 & Day120 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To observe the impact of intervention on migraine-free intervals, evaluating whether it helps prolong the time between episodes & reduces the likelihood of future attacks. 2. To compare the severity of pain based on Visual Analog Scale (VAS) between the two groups. 3. To compare the enhancement of mood between the two groups by using the Brief Mood Introspection Scale (BMIS) 4. Functional Assessment of migraine scale (FAM) Timepoint: Day0 (Baseline),Day15 (2 weeks),Day30,Day60,Day90 & Day120 | — |
Countries
India
Contacts
Vivforever