Health Condition 1: null- Common migraine headache
Conditions
Interventions
Intervention1: Sodium valproate: Sodium valproate 500 mg once a day, increased to 500 mg twice a day, if there is no or inadequate response for 3 months
Control Intervention1: Propranolol: Propranolol
Sponsors
Dr Vikas Sohanlal Sharma
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with history of migraine without aura for at least 6 months prior to evaluation of study. {As per ICHD definition (2.1.1)} 2. Patients experience 2-6 migraine attacks per month, but not more than 15 headache days per month. 3. Male or female patients in the age group of 18-60 years (both inclusive). 4. Patients willing to sign Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. Patients have more than 15 headache days per month or less than 2 migraine attacks per month. 2. Pregnant women or nursing mothers. 3. Women of child-bearing potential & all men not willing to follow a reliable & effective birth control measure during the course of the study & at least 3 months after the last visit. 4. Patients have commenced any form of migraine prophylactic therapy within 1 month preceding the trial. 5. Patients need antidepressant medicines. 6. Patientâ??s headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease or psychosis. 7. Patients with known history of bronchial asthma. 8. Patients with known history of dyslipidemia. 9. Patients with diabetes mellitus, uncontrolled hypertension, epilepsy or other co-existing disease for which they require a concomitant medication with anti-migraine activity, such as: beta blocker, calcium channel blockers, antidepressants or antiepileptics. 10. Patients with history of overuse or require rescue medication for acute migraine treatment for more than 10 treatment days per month or more than 3 days per week. Rescue mediaction: Erogts or triptans, antiemetics, NSAIDS & non opiate analgesics, opiate analgesics, barbiturate hypnotics, corticosteroids, local anesthetics, botulinum toxin or anti-migraine herbal preparations. 11. History of acute myocardial infarction or stroke in 6 months preceding the signing of Informed Consent Form. 12. History of alcohol or drug dependence. 13. Unlikely to maintain a headache diary, comply with the medication or be regular in follow-up visits. 14. Any serious disease that would interfere with the compliance to the study protocol. 15. These criterias are based on past medical history. Development of exclusion criteria after patient has been randomized will not automatically warrant discontinuing subject from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Frequency of migraine attacks. 2.Intensity of migraine attacks. 3.Duration of migraine attacks. 4.Responder rate of more than 50%. Timepoint: 0 week, 4 weeks, 8 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Quality of life assessed by Short Form 12 (SF-12). 2.Disability between two attacks of migraine assessed by Migraine Interictal Burden Scale 4 (MIBS-4). 3.Comorbidities assessed by Generalized Anxiety Disorder Scale 7 (GAD-7) & Patient Health Questionnaire 9 (PHQ-9). 4.Migraine disability assessed by Migraine Disability Assessment (MIDAS) scale. Timepoint: All secondary efficacy variables will be assessed at the start (0 week) & at the end of the study (12 weeks) | — |
Countries
India
Contacts
Public ContactDr Vikas Sohanlal Sharma
Government Medical College Nagpur
Outcome results
None listed