Cupping and Serkangabin Versus Conventional Migraine Treatment

Phase 4

Completed

• Conditions: Migraine Headache
• Interventions: Procedure: cupping and serkangabin syrup; Drug: conventional migraine drug treatment

• Registration Number: NCT01476930
• Lead Sponsor: Birjand University of Medical Sciences

Brief Summary

Migraine is the most common recurrent headache. Current therapy of migraine headache consists of multiple drug groups for control of attack and prophylaxis against recurrent attacks. Emerging alternative medicine worldwide led investigators to evaluate the efficacy of cupping therapy plus SERKANGABIN syrup in treatment of migraine headache. Severity, duration and frequency of attacks of migraine headache evaluated in two groups during six months from presentation.

Detailed Description

In a randomized controlled trial investigators randomly assigned 76 patients with migraine to cupping therapy plus SERKANGABIN or to receive conventional medical treatment. The use of CAM in migraine is a growing phenomenon. Migraine patients seek and explore both conventional and CAM approaches. Wet cupping is an ancient medical technique still used in several contemporary societies. It is being used in management of hypertension, diabetes mellitus, and headaches, renal and biliary stones and for maintaining health. Little experimental study has been devoted to test its efficacy to treat migraine headache. Investigators planned this study for evaluation of therapeutic efficacy of wet cupping and an Iranian traditional medicine preparation, SERKANGABIN in treatment of migraine headache compared with current medicine protocols. SERKANGABIN is a preparation of honey, vinegar and distilled mint water that in traditional Iranian medicine is believed to have therapeutic effects in many diseases (diabetes mellitus, hypertension, hyperlipidemia, osteoarthritis, chronic obstructive airway disease, interstitial lung disease, hepatitis, fatty liver, ischemic heart disease, migraine, cerebrovascular diseases)

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-09
• Study Completion: 2011-10
• Study First Submitted: 2011-11-14
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

• migraine headache with or without aura

Exclusion Criteria

• uncontrolled hypertension
• ischemic heart disease
• cardiac arrhythmia or symptomatic Wolff-Parkinson-White syndrome
• previous stroke or transient ischemic attack
• severe liver or renal impairment
• any other severe or disabling medical condition
• history of alcohol or analgesic or psychotropic drug abuse
• contraindication to or known hypersensitivity to study drugs
• current use or use in the previous 2 weeks of MAO-inhibitors
• a pain disorder other than migraine as the primary presenting problem
• current psychological treatment, psychiatric disorder needing immediate or priority treatment
• current or planned breast feeding or pregnancy or unwillingness to use an established contraceptive method
• non compliance of patients
• not presenting at times determined for treatment and evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cupping serkangabin	cupping and serkangabin syrup	migraine cases treated by cupping and serkangabin syrup
conventional	conventional migraine drug treatment	migraine cases treated by conventional drug treatment protocols

Primary Outcome Measures

Name	Time	Method
frequency of migraine attacks per week	2 weeks after first presentation	endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols

Secondary Outcome Measures

Name	Time	Method
severity of migraine attacks	6 months after first presentation	severity of migraine attacks evaluated 6 months after first presentation in two study groups
frequency of migraine attacks	6 months after first presentation	frequency of migraine attacks evaluated 6 months after first presentation in two study groups
duration of migraine attacks	6 months after first presentation	duration of migraine attacks evaluated 6 months after first presentation in two study groups

Trial Locations

Locations (1)

Birjand University of Medical Sciences,Valiasr Hospital; 🇮🇷 Birjand, South Khorasan, Iran, Islamic Republic of