Cupping and Serkangabin Versus Conventional Migraine Treatment

November 20, 2014 updated by: Birjand University of Medical Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
391

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • South Khorasan
      • Birjand, South Khorasan, Iran, Islamic Republic of, 9714815395
        • Birjand University of Medical Sciences,Valiasr Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cupping serkangabin
migraine cases treated by cupping and serkangabin syrup
Procedure: cupping and serkangabin syrup
wet cupping serkangabin syrup
Active Comparator: conventional
migraine cases treated by conventional drug treatment protocols
Drug: conventional migraine drug treatment
nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
frequency of migraine attacks per week
Time Frame: 2 weeks after first presentation
endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols
2 weeks after first presentation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
severity of migraine attacks
Time Frame: 2 weeks after first presentation
severity of migraine attacks evaluated 2 weeks after first presentation in two study groups
2 weeks after first presentation
duration of migraine attacks
Time Frame: 2 weeks after first presentation
duration of migraine attacks evaluated 2 weeks after first presentationin two study groups
2 weeks after first presentation
severity of migraine attacks
Time Frame: 1 month after first presentation
severity of migraine attacks evaluated 1 month after first presentation in two study groups
1 month after first presentation
severity of migraine attacks
Time Frame: 3 months after first presentation
severity of migraine attacks evaluated 3 months after first presentation in two study groups
3 months after first presentation
severity of migraine attacks
Time Frame: 6 months after first presentation
severity of migraine attacks evaluated 6 months after first presentation in two study groups
6 months after first presentation
duration of migraine attacks
Time Frame: 1 month after first presentation
duration of migraine attacks evaluated 1 month after first presentation in two study groups
1 month after first presentation
duration of migraine attacks
Time Frame: 3 months after first presentation
duration of migraine attacks evaluated 3 months after first presentation in two study groups
3 months after first presentation
duration of migraine attacks
Time Frame: 6 months after first presentation
duration of migraine attacks evaluated 6 months after first presentation in two study groups
6 months after first presentation
frequency of migraine attacks
Time Frame: 1 month after first presentation
frequency of migraine attacks evaluated 1 month after first presentation in two study groups
1 month after first presentation
frequency of migraine attacks
Time Frame: 3 months after first presentation
frequency of migraine attacks evaluated 3 months after first presentation in two study groups
3 months after first presentation
frequency of migraine attacks
Time Frame: 6 months after first presentation
frequency of migraine attacks evaluated 6 months after first presentation in two study groups
6 months after first presentation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Birjand University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: mohammad khodashenas roudsari, M.D., assistant proffessor of internal medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • n231
  • n231hej (Other Grant/Funding Number: birjand university of medical sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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