Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks
Primary Purpose
Migraine Headache, Gastric Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
propranolol
Quince's oxymel
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Migraine Headache
Eligibility Criteria
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
Sites / Locations
- Shiraz University of Medical SciencesRecruiting
- Shiraz University of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
propranolol
Quince's oxymel
placebo
Arm Description
Outcomes
Primary Outcome Measures
frequency of headache attacks
duration of headache attacks
Pain Scores as assessed by the Visual Analog Scale
Secondary Outcome Measures
self-reported improvement of upper gastrointestinal symptoms (by percent)
Full Information
NCT ID
NCT02179775
First Posted
June 27, 2014
Last Updated
July 9, 2014
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02179775
Brief Title
Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache, Gastric Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
propranolol
Arm Type
Active Comparator
Arm Title
Quince's oxymel
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
propranolol
Intervention Type
Drug
Intervention Name(s)
Quince's oxymel
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
frequency of headache attacks
Time Frame
4 weeks
Title
duration of headache attacks
Time Frame
4 weeks
Title
Pain Scores as assessed by the Visual Analog Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
self-reported improvement of upper gastrointestinal symptoms (by percent)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdolhamid Shariat, MD, Assistant Professor
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
+98711
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shariat, MD
Email
shariat123@gmail.com
First Name & Middle Initial & Last Name & Degree
Abdolhamid Shariat, MD
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
+98711
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashempur, MD, PhD
Email
hashempur@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohammad H Hashempur, MD,PhD
12. IPD Sharing Statement
Learn more about this trial
Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks
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