Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: Oral Flunarizine and Co-enzyme Q: Oral Flunarizine at 10 mg/day in a once-daily dose with cap Coenzyme Q orally at a dose of 100 mg/day for 24 weeks
Control Intervention1: Oral Flunari
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with age 6-18 years 2. Newly diagnosed to have migraine with/without aura 3. Not received any medication for migraine prophylaxis in the past three months 4. Caregivers giving informed consent
Exclusion criteria
Exclusion criteria: 1. Already on other prophylactic treatment for migraine 2. Receiving any antioxidant/other herbal medication/nutraceuticals in the past three months 3. Any major systemic illnessAny other associated neurological disorder 4. Abnormality in neuroimaging (MRI brain/CT brain)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Comparison of the reduction in the number of headache days per month at baseline for the 3 months prior to study initiation as compared to the last 4 weeks of treatment in both arms. It will be determined by reviewing the headache diary maintained by the patient and caregivers.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The percentage of responders (subjects with a 50% or more reduction in all of these: mean monthly number of migraine-days and migraine episodes)Timepoint: 24 weeks;2. Reduction in the severity of migraine acute attacks (using the 0â??10 numerical scale) in both arms: each patient will give a numerical score between 0-10 for each headache episode; average severity of all the episodes will be calculated. Weighted severity average of migraine of all the participants in each arm will than calculated taking into account individual frequency of migraine headache episodes. This weighted severity average in both arms will be compared.Timepoint: 24 weeks;3. Reduction in the duration of migraine episodes: average duration of all headache episodes for each participant and than for all participants in each group will be determined, and then comparison between both arms will be carried outTimepoint: 24 weeks;4. Reduction in associated migraine symptoms (e.g. photophobia, phonophobia, nausea, vomiting, and abdominal pain): average frequency of all these symptoms in both arms will be comparedTimepoint: 24 weeks;5. Reduction in disability using PedMIDAS: this score will be calculated at baseline and after 24 weeks of treatment for each participant in each armTimepoint: 24 weeks;6. Change in the quality of life using PedsQL 4.0.: this score will be calculated at baseline and after 24 weeks of treatment for each participant in each armTimepoint: 24 weeks;7. Change in blood coenzyme Q levels in each armTimepoint: 24 weeks;8. Change in arterial blood lactate level: Arterial lactate level will be measured in each participant at baseline and after 24 weeksTimepoint: 24 weeks | — |
Countries
India
Contacts
Public ContactIndar Kumar Sharawat
AIIMS, Rishikesh
Outcome results
None listed