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Evaluation of the effectiveness of Iraj Fiqra herbal pills in the treatment of migraine headaches

Phase 3
Recruiting
Conditions
Migraine.
G43.0
Migraine without aura
Registration Number
IRCT20081208001497N9
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
60
Inclusion Criteria

Having migraine without aura (according to the criteria of the International Headache Association (HIS), which is diagnosed by the physician
Age between 18 and 65
History of migraine of at least one year
The first migraine attack at the age of less than fifty years
Have at least three attacks per month in the last three months
Having a score higher than 6 according to the MIDAS questionnaire

Exclusion Criteria

Having headaches between two migraine attacks that are indistinguishable from migraine attacks
Chronic tension headache or other types of headache for more than 15 days a month
Pregnancy and lactation
The presence of underlying heart problems such as arrhythmias
History of biliary problems
Comorbidities with inflammatory bowel diseases such as ulcerative colitis and Crohn's disease
History of hemorrhoids
Concomitant use of sedatives such as phenobarbital
Concomitant use of diuretics, oral corticosteroids
Concomitant use of laxatives such as polyethylene glycol or magnesium hydroxide
Daily consumption of migraine prophylaxis for the past month
Take at least three migraine medications for prophylaxis over the past ten years
Drug or alcohol abuse
Patient dissatisfaction

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Evaluation of the number of migraine attacks. Timepoint: Upon arrival, first and second month. Method of measurement: MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6).;Evaluation of the severity of migraine attacks. Timepoint: Upon arrival, first and second month. Method of measurement: MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6).;Evaluation of the duration of migraine attacks. Timepoint: Upon arrival, first and second month. Method of measurement: MIDAS questionnaire (migraine disability assessment) and HIT-6 questionnaire (headache impact test -6).
Secondary Outcome Measures
NameTimeMethod
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