Effect of Oregano nasal spray on migraine
Phase 3
- Conditions
- Migraine headache.G43.0Migraine without aura [common migraine]
- Registration Number
- IRCT20220601055051N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Migraine based on IHS criteria
2 to 8 migraine attack in a month with less than 15 days headache a month and with at least 48 hours intervals
Onset of headaches less than one year ago
No warm brain temperament
18 to 65 years old with headache onset no later than 50 years old
Exclusion Criteria
Secondary headaches
Regular use of antipsychotic or antidepressant drugs during last 3 months for reasons other than migraine
Alcohol or drug abuse
Drug sensitivity to the drug ingredients
Fertile women with no contraception
Pregnancy and breast feeding
consuming drugs affecting migraine headache or interacting with drug ingredients during last week
Analgesic overuse based on IHS criteria
Severe physical or psychologic disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of migraine headache attacks per month. Timepoint: Three times with one month intervals. Method of measurement: Number of attacks with at least 48 hours of freedom from headache between migraine attacks.
- Secondary Outcome Measures
Name Time Method Headache severity. Timepoint: Tree times with one month intervals. Method of measurement: Four point verbal scale.;Number and name of analgesics used. Timepoint: Three times with one month intervals. Method of measurement: Recording the name and the number of analgesics used in one month.;Health related quality of life. Timepoint: Three times with one month intervals. Method of measurement: Sf 36 & hit 6 questionaire.