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

• Sponsor: Shiraz University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02179775
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Arms: 3
• Duration (Months): 3
• Patients Per Site: 22.5
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Headache; Gastric Diseases	Drug: propranolol; Drug: Quince's oxymel; Drug: placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jul 1, 2014
• Anticipated Primary Completion Date: Sep 1, 2014
• Anticipated Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: propranolol	Drug: propranolol
Active Comparator: Quince's oxymel	Drug: Quince's oxymel
Placebo Comparator: placebo	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. frequency of headache attacks [4 weeks]

2. duration of headache attacks [4 weeks]

3. Pain Scores as assessed by the Visual Analog Scale [4 weeks]

Secondary Outcome Measures

1. self-reported improvement of upper gastrointestinal symptoms (by percent) [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiraz University of Medical Sciences	Shiraz	Fars	Iran, Islamic Republic of	+98711
2	Shiraz University of Medical Sciences	Shiraz	Fars	Iran, Islamic Republic of	+98711

Sponsors and Collaborators

• Shiraz University of Medical Sciences

Investigators

• Principal Investigator: Abdolhamid Shariat, MD, Assistant Professor, Shiraz University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammad Hashem Hashempur, MD, PhD of Iranian traditional medicine, Shiraz University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02179775
• Other Study ID Numbers: 90-01-64-3456
• First Posted: Jul 2, 2014
• Last Update Posted: Jul 10, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Stomach Diseases; Migraine Disorders; Headache; Propranolol

Study Results

No Results Posted as of Jul 10, 2014