Cupping and Serkangabin Versus Conventional Migraine Treatment

Migraine Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476930
• Other study ID #: n231
• Secondary ID: n231hej
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2011
• Last updated: November 20, 2014
• Start date: June 2008
• Est. completion date: October 2011

Study information

• Verified date: November 2014
• Source: Birjand University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: October 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Procedure:
• cupping and serkangabin syrup
wet cupping serkangabin syrup

Drug:
• conventional migraine drug treatment
nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

Locations

Country	Name	City	State
Iran, Islamic Republic of	Birjand University of Medical Sciences,Valiasr Hospital	Birjand	South Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Birjand University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	severity of migraine attacks	severity of migraine attacks evaluated 2 weeks after first presentation in two study groups	2 weeks after first presentation	No
Secondary	duration of migraine attacks	duration of migraine attacks evaluated 2 weeks after first presentationin two study groups	2 weeks after first presentation	No
Secondary	severity of migraine attacks	severity of migraine attacks evaluated 1 month after first presentation in two study groups	1 month after first presentation	No
Secondary	severity of migraine attacks	severity of migraine attacks evaluated 3 months after first presentation in two study groups	3 months after first presentation	No
Secondary	severity of migraine attacks	severity of migraine attacks evaluated 6 months after first presentation in two study groups	6 months after first presentation	No
Secondary	duration of migraine attacks	duration of migraine attacks evaluated 1 month after first presentation in two study groups	1 month after first presentation	No
Secondary	duration of migraine attacks	duration of migraine attacks evaluated 3 months after first presentation in two study groups	3 months after first presentation	No
Secondary	duration of migraine attacks	duration of migraine attacks evaluated 6 months after first presentation in two study groups	6 months after first presentation	No
Secondary	frequency of migraine attacks	frequency of migraine attacks evaluated 1 month after first presentation in two study groups	1 month after first presentation	No
Secondary	frequency of migraine attacks	frequency of migraine attacks evaluated 3 months after first presentation in two study groups	3 months after first presentation	No
Secondary	frequency of migraine attacks	frequency of migraine attacks evaluated 6 months after first presentation in two study groups	6 months after first presentation	No