Effect of "Sekanjabin e Safarjali" (Quince Oxymel) in the Prevention of Migraine Attacks
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
1 other identifier
interventional
45
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJuly 10, 2014
July 1, 2014
2 months
June 27, 2014
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
frequency of headache attacks
4 weeks
duration of headache attacks
4 weeks
Pain Scores as assessed by the Visual Analog Scale
4 weeks
Secondary Outcomes (1)
self-reported improvement of upper gastrointestinal symptoms (by percent)
4 weeks
Study Arms (3)
propranolol
ACTIVE COMPARATORQuince's oxymel
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- minimum age of 18 years old
- giving a written informed consent
- having at least 2 migraine attacks per month
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shiraz University of Medical Sciences
Shiraz, Fars, +98711, Iran
Shiraz University of Medical Sciences
Shiraz, Fars, +98711, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abdolhamid Shariat, MD, Assistant Professor
Shiraz University of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD of Iranian traditional medicine
Study Record Dates
First Submitted
June 27, 2014
First Posted
July 2, 2014
Study Start
July 1, 2014
Primary Completion
September 1, 2014
Study Completion
October 1, 2014
Last Updated
July 10, 2014
Record last verified: 2014-07