Cupping and Serkangabin Versus Conventional Migraine Treatment

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Migraine Headache

Intervention / Treatment
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* Procedure: cupping and serkangabin syrup
* Drug: conventional migraine drug treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, prophylactic treatment, cupping, serkangabin