Cupping and Serkangabin Versus Conventional Migraine Treatment

Overview

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.

Full Title of Study: “Cupping Therapy and SERKANGABIN Versus Conventional Treatment of Migraine Headache: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2009

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)

Interventions

  • Procedure: cupping and serkangabin syrup
    • wet cupping serkangabin syrup
  • Drug: conventional migraine drug treatment
    • nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

Arms, Groups and Cohorts

  • Experimental: cupping serkangabin
    • migraine cases treated by cupping and serkangabin syrup
  • Active Comparator: conventional
    • migraine cases treated by conventional drug treatment protocols

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • severity of migraine attacks
    • Time Frame: 2 weeks after first presentation
    • 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
    • duration of migraine attacks evaluated 2 weeks after first presentationin two study groups
  • severity of migraine attacks
    • Time Frame: 1 month after first presentation
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • 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
    • frequency of migraine attacks evaluated 6 months after first presentation in two study groups

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Birjand University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • mohammad khodashenas roudsari, M.D., Study Chair, assistant proffessor of internal medicine

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