Effect of Sekanjabin e Safarjali (Quince Oxymel) in the Prevention of Migraine Attacks

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Quince Oxymel is effective in the prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.

Detailed Description
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This is a randomized, placebo-controlled, triple blinded clinical study to evaluate the effects of oral use of Sekanjebin e Safarjali (Quince Oxymel) in the Prevention of Migraine attacks in patients with simultaneous upper gastrointestinal dysfunction.45 patients with Migraine headache aged between 15-70, after taking signed informed consent, according to the International headache society criteria for headache [2] are included in this trial. 45 cases with Migraine headache with simultaneous upper gastrointestinal dysfunction will allocate to three arms by using simple randomization. Quince Oxymel, propranolol and placebo will be given as encoded, innominate bottles with the same shape and color. Quince oxymel and placebo will be prescribed as 10 cc, three times a day for 4 weeks. Frequency, duration and intensity of Migraine Attacks at the beginning time and during 4 weeks of trial, will be evaluated, as the primary outcome measures.

Official Title
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Comparison of Effectiveness of Sekanjabin e Safarjali (Quince Oxymel), Propranolol and Placebo in the Prevention of Migraine Attacks in Patients With Simultaneous Upper Gastrointestinal Dysfunction

Conditions
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Migraine Headache, Gastric Diseases

Intervention / Treatment
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* Drug: propranolol
* Drug: Quince's oxymel
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: minimum age of 18 years old giving a written informed consent having at least 2 migraine attacks per month Exclusion Criteria: patients older than 70 years old patients with Diabetes mellitus patients with chronic obstructive pulmonary disease and asthma pregnancy severe depression patients affected by sexual disorders bradyarrhythmic patients positive history of hypersensitivity reactions to quince, ginger, propranolol or naproxen

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propranolol<br> | Drug: propranolol<br> <br> |
| Active Comparator: Quince's oxymel<br> | Drug: Quince's oxymel<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of headache attacks |  | 4 weeks | 
| duration of headache attacks |  | 4 weeks | 
| Pain Scores as assessed by the Visual Analog Scale |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported improvement of upper gastrointestinal symptoms (by percent) |  | 4 weeks |