RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO COMPARE THE EFFICACY OF PROPRANOLOL WITH PLACEBO FOR THE PROPHYLAXIS OF MIGRAINE IN CHILDRE
Phase 3
Completed
- Conditions
- Migraine without auraMigrainePropranololPlacebo
- Registration Number
- TCTR20200621001
- Lead Sponsor
- Maulana Azad Medical College, Bahadur shah zafar marg, New Delhi.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
•Diagnosed with Migraine without aura as per International Classification of Headache Disorders, 3rd Edition (ICHD-3) (Annexure-4).
•Either >3 missed school days or >3 severe headaches per month.
Exclusion Criteria
•Diagnosed with another co-existent headache disorder;
•Co-existent asthma or cardiovascular disease that preclude the use of propranolol;
•Receiving prophylaxis with any medication, currently or in past 3 months;
•Receiving any anti-convulsant drug, currently or in past 3 months; and
•Receiving Complementary and alternative medications (CAM).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of migraine attacks 3 months Headache diary
- Secondary Outcome Measures
Name Time Method the frequency of migraine attacks 3 months manual