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Evaluation of magnesium effect in treatment of migraine

Phase 3
Conditions
Migraine.
Migraine
Registration Number
IRCT20221115056506N1
Lead Sponsor
Shiraz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
140
Inclusion Criteria

Age from 6 to 18 years old
Weight less than 90 Kg
Diagnosed as migraine according to IHSC-3 criteria
At least 4 migraine attacks in month or 8 days-of-headache during at least 1 month ago

Exclusion Criteria

Coexistence of another type of headache
Migrainous headache in at least 15 days per month
Using analgesic medications in at least 15 days per month
Pregnancy or intention of pregnancy
History of epilepsy or other neurological comorbidities
Mental retardation defined as IQ<70
Dependency or addiction to pharmaceutical or illicit drugs
Magnesium administration contraindications
Renal failure
History of renal stone
Propranolol administration contraindications
Cardiac conduction block
Bradycardia
History of asthma
History of hypersensitivity reaction to propranolol
Diabetes mellitus
Liver insufficiency
Myasthenia gravis
Psoriasis
History of using migraine prophylaxis medications in the past month
History of using magnesium supplements in the past month
History of psychiatric disorders including depression, mood disorders, anxiety disorders or psychotic disorders
History of using anti-depressants, anti-psychotics, mood stabilizers or sedatives
Anticipation of patient's poor medication compliance
Illiteracy of the patient and family and, inability of filling the diary

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Frequency of migraine attacks per month. Timepoint: At the beginning; then, 4 weeks later; then, 12 weeks after the initiation. Method of measurement: Direct asking of the patient in the first visit; then, using migraine diary in the following visits.
Secondary Outcome Measures
NameTimeMethod
Severity of pain during migraine attacks. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: Wong-baker scale.;Average duration of migraine attacks per month. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: direct asking and migraine diary.;Amount of analgesic medications used. Timepoint: First visit; 4 weeks later; 12 weeks later. Method of measurement: direct asking and migraine diary.
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