Cupping and Serkangabin Versus Conventional Migraine Treatment

Cupping Therapy and SERKANGABIN Versus Conventional Treatment of Migraine Headache: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Procedure: cupping and serkangabin syrup; Drug: conventional migraine drug treatment

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 Type: Interventional
• Enrollment (Actual): 391
• Phase: Phase 4

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • South Khorasan
    • Birjand, South Khorasan, Iran, Islamic Republic of, 9714815395
      • Birjand University of Medical Sciences,Valiasr Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cupping serkangabin; migraine cases treated by cupping and serkangabin syrup	Procedure: cupping and serkangabin syrup; wet cupping serkangabin syrup
Active Comparator: conventional; migraine cases treated by conventional drug treatment protocols	Drug: conventional migraine drug treatment; nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of migraine attacks per week	endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols	2 weeks after first presentation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of migraine attacks	severity of migraine attacks evaluated 2 weeks after first presentation in two study groups	2 weeks after first presentation
duration of migraine attacks	duration of migraine attacks evaluated 2 weeks after first presentationin two study groups	2 weeks after first presentation
severity of migraine attacks	severity of migraine attacks evaluated 1 month after first presentation in two study groups	1 month after first presentation
severity of migraine attacks	severity of migraine attacks evaluated 3 months after first presentation in two study groups	3 months after first presentation
severity of migraine attacks	severity of migraine attacks evaluated 6 months after first presentation in two study groups	6 months after first presentation
duration of migraine attacks	duration of migraine attacks evaluated 1 month after first presentation in two study groups	1 month after first presentation
duration of migraine attacks	duration of migraine attacks evaluated 3 months after first presentation in two study groups	3 months after first presentation
duration of migraine attacks	duration of migraine attacks evaluated 6 months after first presentation in two study groups	6 months after first presentation
frequency of migraine attacks	frequency of migraine attacks evaluated 1 month after first presentation in two study groups	1 month after first presentation
frequency of migraine attacks	frequency of migraine attacks evaluated 3 months after first presentation in two study groups	3 months after first presentation
frequency of migraine attacks	frequency of migraine attacks evaluated 6 months after first presentation in two study groups	6 months after first presentation

Collaborators and Investigators

• Sponsor: Birjand University of Medical Sciences
• Investigators: Study Chair: mohammad khodashenas roudsari, M.D., assistant proffessor of internal medicine

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 24, 2014
• Last Update Submitted That Met QC Criteria: November 20, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: migraine; cupping; prophylactic treatment; serkangabin
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: n231; n231hej (Other Grant/Funding Number: birjand university of medical sciences)