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

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02179775
• Other study ID #: 90-01-64-3456
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2014
• Last updated: July 9, 2014
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: July 2014
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gastric Diseases
• Migraine Disorders
• Migraine Headache
• Stomach Diseases

Intervention

Drug:
• propranolol

• Quince's oxymel

• placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of headache attacks		4 weeks	No
Primary	duration of headache attacks		4 weeks	No
Primary	Pain Scores as assessed by the Visual Analog Scale		4 weeks	No
Secondary	self-reported improvement of upper gastrointestinal symptoms (by percent)		4 weeks	No