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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
45
Shiraz University of Medical Sciences
Shiraz, Fars, Iran
RECRUITINGShiraz University of Medical Sciences
Shiraz, Fars, Iran
RECRUITINGfrequency of headache attacks
Time frame: 4 weeks
duration of headache attacks
Time frame: 4 weeks
Pain Scores as assessed by the Visual Analog Scale
Time frame: 4 weeks
self-reported improvement of upper gastrointestinal symptoms (by percent)
Time frame: 4 weeks
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