Comparison of effectiveness & safety of sodium valproate versus propranolol in prevention of common migraine headache
- Conditions
- Health Condition 1: null- Common migraine headache
- Registration Number
- CTRI/2017/10/010241
- Lead Sponsor
- Dr Vikas Sohanlal Sharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method