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Amitriptyline and melatonin in prophylaxis of of migraine in childre

Not Applicable
Completed
Conditions
Migraine headache.
Migraine without aura [common migraine
Registration Number
IRCT201305292639N12
Lead Sponsor
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

1. children aged 5-15 years 2. Having migraine headache based on International Headache Society Criteria 3. Having frequent ( one or more headache attack per week ) or disabling ( PedMIDAS more than 20) headaches that prophylactic therapy indicated in them . in one month 4. not used any migraine preventive therapy

Exclusion Criteria

1. History of drug allergy 2. Secondary headaches such as epilepsy or other neurologic disorders 3. Systemic diseases such as asthma, diabetes mellitus , metabolic acidosis , renal stone and hepatic diseases

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Monthly frequency of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Severity of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Duration of headache. Timepoint: before and three months after treatment. Method of measurement: asking from patient.;Pediatric Migraine Disability score. Timepoint: before and three months after treatment. Method of measurement: asking from patient.
Secondary Outcome Measures
NameTimeMethod
Side effects. Timepoint: monthly until three months after treatment. Method of measurement: clinical exam and asking from patients.
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