None listed
Conditions
Interventions
Intervention1: Riboflavin: 20 mg B.D. for 3 months
Control Intervention1: Propranolol: 40 mg b.d. for 3 months
Control Intervention2: Placebo: B.D. For 3 Months
Sponsors
Dr. Y K Gupta
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient of either sex between age group18-65 years who have not received any drug for migraine prophylaxis before. 2.Medical history consistent with migraine with or without aura according to the International Headache Society (IHS) for at least 1 year prior to the study. 3.More than four migraine episodes per month but no greater than 15 headache days (migraine and non-migraine) in one month during the baseline phase. There should be a gap of at least 48 hours between two episodes. Frequency of non-migraine headaches should be no more than 6 episodes per month. 4.No significant abnormalities on clinical examination at baseline. 5.Female patients must be either postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception during the complete study period. 6.Willing to provide informed consent. 7.Patients able to maintain a headache diary.
Exclusion criteria
Exclusion criteria: 1.Patients with headaches other than migraine who cannot differentiate migraine from other headaches. 2.Onset of migraine after age of 50 years 3.Patients who have taken antipsychotics or antidepressants during the previous 3 months. 4.Patients who abuse alcohol or other drugs. 5.Patients who use drugs excessively for headache (more than 10 days per month). 6.Pregnant or lactating women 7.Patients with heart or kidney diseases, asthma or diabetes or otherwise unhealthy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who achieved 50% or greater decrease in the number of migraine attacks during the 3rd month, compared to the run-in month.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Percentage of patients who achieved 50% or greater decrease in the number of migraine days during the 3rd month, compared to the run-in month. ?Difference between the two groups in the third month regarding the use of rescue medications and regarding the adverse effects.Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr. Y K Gupta
Outcome results
None listed