Clinical trial NCT01476930: Cupping and Serkangabin Versus Conventional Migraine Treatment
Official title: Cupping Therapy and SERKANGABIN Versus Conventional Treatment of Migraine Headache: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Headache
Keywords: migraine
prophylactic treatment
cupping
serkangabin
Lead sponsor: Birjand University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 391
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: frequency of migraine attacks per week
timeFrame: 2 weeks after first presentation
Secondary outcomes:
measure: severity of migraine attacks
timeFrame: 2 weeks after first presentation
measure: duration of migraine attacks
timeFrame: 2 weeks after first presentation
measure: severity of migraine attacks
timeFrame: 1 month after first presentation
measure: severity of migraine attacks
timeFrame: 3 months after first presentation
measure: severity of migraine attacks
timeFrame: 6 months after first presentation
measure: duration of migraine attacks
timeFrame: 1 month after first presentation
measure: duration of migraine attacks
timeFrame: 3 months after first presentation
measure: duration of migraine attacks
timeFrame: 6 months after first presentation
measure: frequency of migraine attacks
timeFrame: 1 month after first presentation
measure: frequency of migraine attacks
timeFrame: 3 months after first presentation
measure: frequency of migraine attacks
timeFrame: 6 months after first presentation
Other outcomes:
Locations:
city: Birjand
country: Iran, Islamic Republic of
facility: Birjand University of Medical Sciences,Valiasr Hospital
state: South Khorasan
Study officials:
affiliation: assistant proffessor of internal medicine
name: mohammad khodashenas roudsari, M.D.
role: STUDY_CHAIR
References: