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Cupping and Serkangabin Versus Conventional Migraine Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Birjand University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01476930
First received: November 14, 2011
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Migraine Headache
 Procedure: cupping and serkangabin syrup
Drug: conventional migraine drug treatment
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cupping Therapy and SERKANGABIN Versus Conventional Treatment of Migraine Headache: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Birjand University of Medical Sciences:

Primary Outcome Measures:
  • frequency of migraine attacks per week [ Time Frame: 2 weeks after first presentation ] [ Designated as safety issue: No ]
    endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols


Secondary Outcome Measures:
  • severity of migraine attacks [ Time Frame: 2 weeks after first presentation ] [ Designated as safety issue: No ]
    severity of migraine attacks evaluated 2 weeks after first presentation in two study groups

  • duration of migraine attacks [ Time Frame: 2 weeks after first presentation ] [ Designated as safety issue: No ]
    duration of migraine attacks evaluated 2 weeks after first presentationin two study groups

  • severity of migraine attacks [ Time Frame: 1 month after first presentation ] [ Designated as safety issue: No ]
    severity of migraine attacks evaluated 1 month after first presentation in two study groups

  • severity of migraine attacks [ Time Frame: 3 months after first presentation ] [ Designated as safety issue: No ]
    severity of migraine attacks evaluated 3 months after first presentation in two study groups

  • severity of migraine attacks [ Time Frame: 6 months after first presentation ] [ Designated as safety issue: No ]
    severity of migraine attacks evaluated 6 months after first presentation in two study groups

  • duration of migraine attacks [ Time Frame: 1 month after first presentation ] [ Designated as safety issue: No ]
    duration of migraine attacks evaluated 1 month after first presentation in two study groups

  • duration of migraine attacks [ Time Frame: 3 months after first presentation ] [ Designated as safety issue: No ]
    duration of migraine attacks evaluated 3 months after first presentation in two study groups

  • duration of migraine attacks [ Time Frame: 6 months after first presentation ] [ Designated as safety issue: No ]
    duration of migraine attacks evaluated 6 months after first presentation in two study groups

  • frequency of migraine attacks [ Time Frame: 1 month after first presentation ] [ Designated as safety issue: No ]
    frequency of migraine attacks evaluated 1 month after first presentation in two study groups

  • frequency of migraine attacks [ Time Frame: 3 months after first presentation ] [ Designated as safety issue: No ]
    frequency of migraine attacks evaluated 3 months after first presentation in two study groups

  • frequency of migraine attacks [ Time Frame: 6 months after first presentation ] [ Designated as safety issue: No ]
    frequency of migraine attacks evaluated 6 months after first presentation in two study groups


Enrollment: 391
Study Start Date: June 2008
Study Completion Date: October 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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)

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476930

Locations
Iran, Islamic Republic of
Birjand University of Medical Sciences,Valiasr Hospital
Birjand, South Khorasan, Iran, Islamic Republic of, 9714815395
Sponsors and Collaborators
Birjand University of Medical Sciences
Investigators
Study Director: mohammad dehghanifiroozabadi, M.D. assistant proffessor of neurology
  More Information

No publications provided

Responsible Party: Birjand University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01476930     History of Changes
Other Study ID Numbers: n231, n231hej
Study First Received: November 14, 2011
Last Updated: November 18, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Birjand University of Medical Sciences:
migraine
prophylactic treatment
cupping
serkangabin

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013