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Cupping and Serkangabin Versus Conventional Migraine Treatment

NCT ID: NCT01476930

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

391 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-10-31

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)

Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cupping serkangabin

migraine cases treated by cupping and serkangabin syrup

Group Type EXPERIMENTAL

cupping and serkangabin syrup

Intervention Type PROCEDURE

wet cupping serkangabin syrup

conventional

migraine cases treated by conventional drug treatment protocols

Group Type ACTIVE_COMPARATOR

conventional migraine drug treatment

Intervention Type DRUG

nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

Interventions

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cupping and serkangabin syrup

wet cupping serkangabin syrup

Intervention Type PROCEDURE

conventional migraine drug treatment

nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

Intervention Type DRUG

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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Birjand University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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mohammad khodashenas roudsari, M.D.

Role: STUDY_CHAIR

assistant proffessor of internal medicine

Locations

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Birjand University of Medical Sciences,Valiasr Hospital

Birjand, South Khorasan Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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n231hej

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

n231

Identifier Type: -

Identifier Source: org_study_id