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NCT Number: NCT01476930

Cupping and Serkangabin Versus Conventional Migraine Treatment

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.

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Key information

Conditions

Migraine Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birjand University of Medical Sciences,Valiasr Hospital

Birjand, South Khorasan Province, 9714815395, Iran

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cupping and serkangabin syrup

Procedure

wet cupping serkangabin syrup

conventional migraine drug treatment

Drug

nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

Primary outcomes

  1. 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 outcomes

  1. 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

  2. duration of migraine attacks

    Time frame: 2 weeks after first presentation

    duration of migraine attacks evaluated 2 weeks after first presentationin two study groups

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Birjand University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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