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

Not Applicable

• Conditions: Migraine Headache; Gastric Diseases
• Interventions: Drug: placebo; Drug: Quince's oxymel; Drug: propranolol

• Registration Number: NCT02179775
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-06-30
• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Posted: 2014-07-02
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10
• Primary Completion: 2014-09
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
Quince's oxymel	Quince's oxymel	-
propranolol	propranolol	-

Primary Outcome Measures

Name	Time	Method
Pain Scores as assessed by the Visual Analog Scale	4 weeks
frequency of headache attacks	4 weeks
duration of headache attacks	4 weeks

Secondary Outcome Measures

Name	Time	Method
self-reported improvement of upper gastrointestinal symptoms (by percent)	4 weeks

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of