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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| propranolol | Active Comparator |
| |
| Quince's oxymel | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propranolol | Drug |
| ||
| Quince's oxymel |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| self-reported improvement of upper gastrointestinal symptoms (by percent) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdolhamid Shariat, MD, Assistant Professor | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiraz University of Medical Sciences | Recruiting | Shiraz | Fars | +98711 | Iran |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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|
| placebo | Drug |
|
| Shiraz University of Medical Sciences | Recruiting | Shiraz | Fars | +98711 | Iran |
|
| D009422 | Nervous System Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |