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Cupping and Serkangabin Versus Conventional Migraine Treatment

Primary Purpose

Migraine Headache

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
cupping and serkangabin syrup
conventional migraine drug treatment
Sponsored by
Birjand University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache focused on measuring migraine, prophylactic treatment, cupping, serkangabin

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Birjand University of Medical Sciences,Valiasr Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cupping serkangabin

conventional

Arm Description

migraine cases treated by cupping and serkangabin syrup

migraine cases treated by conventional drug treatment protocols

Outcomes

Primary Outcome Measures

frequency of migraine attacks per week
endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols

Secondary Outcome Measures

severity of migraine attacks
severity of migraine attacks evaluated 2 weeks after first presentation in two study groups
duration of migraine attacks
duration of migraine attacks evaluated 2 weeks after first presentationin two study groups
severity of migraine attacks
severity of migraine attacks evaluated 1 month after first presentation in two study groups
severity of migraine attacks
severity of migraine attacks evaluated 3 months after first presentation in two study groups
severity of migraine attacks
severity of migraine attacks evaluated 6 months after first presentation in two study groups
duration of migraine attacks
duration of migraine attacks evaluated 1 month after first presentation in two study groups
duration of migraine attacks
duration of migraine attacks evaluated 3 months after first presentation in two study groups
duration of migraine attacks
duration of migraine attacks evaluated 6 months after first presentation in two study groups
frequency of migraine attacks
frequency of migraine attacks evaluated 1 month after first presentation in two study groups
frequency of migraine attacks
frequency of migraine attacks evaluated 3 months after first presentation in two study groups
frequency of migraine attacks
frequency of migraine attacks evaluated 6 months after first presentation in two study groups

Full Information

First Posted
November 14, 2011
Last Updated
November 20, 2014
Sponsor
Birjand University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01476930
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birjand University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
migraine, prophylactic treatment, cupping, serkangabin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
391 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cupping serkangabin
Arm Type
Experimental
Arm Description
migraine cases treated by cupping and serkangabin syrup
Arm Title
conventional
Arm Type
Active Comparator
Arm Description
migraine cases treated by conventional drug treatment protocols
Intervention Type
Procedure
Intervention Name(s)
cupping and serkangabin syrup
Intervention Description
wet cupping serkangabin syrup
Intervention Type
Drug
Intervention Name(s)
conventional migraine drug treatment
Intervention Description
nortriptyline ,propranolol ,ergotamine , sumatriptan tablets
Primary Outcome Measure Information:
Title
frequency of migraine attacks per week
Description
endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols
Time Frame
2 weeks after first presentation
Secondary Outcome Measure Information:
Title
severity of migraine attacks
Description
severity of migraine attacks evaluated 2 weeks after first presentation in two study groups
Time Frame
2 weeks after first presentation
Title
duration of migraine attacks
Description
duration of migraine attacks evaluated 2 weeks after first presentationin two study groups
Time Frame
2 weeks after first presentation
Title
severity of migraine attacks
Description
severity of migraine attacks evaluated 1 month after first presentation in two study groups
Time Frame
1 month after first presentation
Title
severity of migraine attacks
Description
severity of migraine attacks evaluated 3 months after first presentation in two study groups
Time Frame
3 months after first presentation
Title
severity of migraine attacks
Description
severity of migraine attacks evaluated 6 months after first presentation in two study groups
Time Frame
6 months after first presentation
Title
duration of migraine attacks
Description
duration of migraine attacks evaluated 1 month after first presentation in two study groups
Time Frame
1 month after first presentation
Title
duration of migraine attacks
Description
duration of migraine attacks evaluated 3 months after first presentation in two study groups
Time Frame
3 months after first presentation
Title
duration of migraine attacks
Description
duration of migraine attacks evaluated 6 months after first presentation in two study groups
Time Frame
6 months after first presentation
Title
frequency of migraine attacks
Description
frequency of migraine attacks evaluated 1 month after first presentation in two study groups
Time Frame
1 month after first presentation
Title
frequency of migraine attacks
Description
frequency of migraine attacks evaluated 3 months after first presentation in two study groups
Time Frame
3 months after first presentation
Title
frequency of migraine attacks
Description
frequency of migraine attacks evaluated 6 months after first presentation in two study groups
Time Frame
6 months after first presentation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammad khodashenas roudsari, M.D.
Organizational Affiliation
assistant proffessor of internal medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Birjand University of Medical Sciences,Valiasr Hospital
City
Birjand
State/Province
South Khorasan
ZIP/Postal Code
9714815395
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Cupping and Serkangabin Versus Conventional Migraine Treatment

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