Migraine HeadachePhase 4NCT01476930
Cupping and Serkangabin Versus Conventional Migraine Treatment
A Phase 4 study testing cupping and serkangabin syrup and conventional migraine drug treatment in people with Migraine Headache, run by Birjand University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Migraine Headache
- What is being tested?
- cupping and serkangabin syrup and conventional migraine drug treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 1 siteIran
- Study dates
- Jun 2008to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- migraine headache with or without aura
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Birjand University of Medical Sciences,Valiasr Hospital
Birjand, South Khorasan Province, 9714815395
About this study
Official title: 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.
Read the 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)
- Conditions
- Migraine Headache
- Being tested
- cupping and serkangabin syrup, conventional migraine drug treatment
- Keywords
- migraine, prophylactic treatment, cupping, serkangabin
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cupping and serkangabin syrupProcedure or surgery
wet cupping serkangabin syrup
conventional migraine drug treatmentDrug
nortriptyline ,propranolol ,ergotamine , sumatriptan tablets
| Study group | Role | What they receive |
|---|---|---|
| cupping serkangabin | Experimental | migraine cases treated by cupping and serkangabin syrup Receives: Procedure: cupping and serkangabin syrup |
| conventional | Active comparator | migraine cases treated by conventional drug treatment protocols Receives: Drug: conventional migraine drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of migraine attacks per week
endpoints evaluated in both study groups 2 weeks after first presentation and receiving treatment protocols
Measured: 2 weeks after first presentation
Secondary outcomes (11)
severity of migraine attacks
severity of migraine attacks evaluated 2 weeks after first presentation in two study groups
Measured: 2 weeks after first presentation
duration of migraine attacks
duration of migraine attacks evaluated 2 weeks after first presentationin two study groups
Measured: 2 weeks after first presentation
severity of migraine attacks
severity of migraine attacks evaluated 1 month after first presentation in two study groups
Measured: 1 month after first presentation
severity of migraine attacks
severity of migraine attacks evaluated 3 months after first presentation in two study groups
Measured: 3 months after first presentation
severity of migraine attacks
severity of migraine attacks evaluated 6 months after first presentation in two study groups
Measured: 6 months after first presentation
duration of migraine attacks
duration of migraine attacks evaluated 1 month after first presentation in two study groups
Measured: 1 month after first presentation
duration of migraine attacks
duration of migraine attacks evaluated 3 months after first presentation in two study groups
Measured: 3 months after first presentation
duration of migraine attacks
duration of migraine attacks evaluated 6 months after first presentation in two study groups
Measured: 6 months after first presentation
frequency of migraine attacks
frequency of migraine attacks evaluated 1 month after first presentation in two study groups
Measured: 1 month after first presentation
frequency of migraine attacks
frequency of migraine attacks evaluated 3 months after first presentation in two study groups
Measured: 3 months after first presentation
frequency of migraine attacks
frequency of migraine attacks evaluated 6 months after first presentation in two study groups
Measured: 6 months after first presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJun 2008
- Primary completionSep 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birjand University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mohammad khodashenas roudsari, M.D., Study chair, assistant proffessor of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476930
- Sponsor's protocol ID
- n231
- Other IDs
- n231hej
- Status last verified
- Nov 2014
- First submitted
- 14 Nov 2011
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cupping Therapy and SERKANGABIN Versus Conventional Treatment of Migraine Headache: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01476930
- Acronym / sponsor ID
- n231
- Conditions
- Migraine Headache
- Keywords
- migraine, prophylactic treatment, cupping, serkangabin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Birjand University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cupping serkangabin | Experimental | Procedure: cupping and serkangabin syrupmigraine cases treated by cupping and serkangabin syrup |
| conventional | Active comparator | Drug: conventional migraine drug treatmentmigraine cases treated by conventional drug treatment protocols |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- migraine headache with or without aura
Key exclusion criteria (14 listed)
- uncontrolled hypertension
- ischemic heart disease
- cardiac arrhythmia or symptomatic Wolff-Parkinson-White syndrome
- previous stroke or transient ischemic attack
- severe liver or renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cupping and serkangabin syrupwet cupping serkangabin syrup | Procedure or surgery | cupping serkangabin |
| conventional migraine drug treatmentnortriptyline ,propranolol ,ergotamine , sumatriptan tablets | Drug | conventional |
Primary outcome
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
11 secondary outcomes
severity of migraine attacks
Time frame: 2 weeks after first presentation
duration of migraine attacks
Time frame: 2 weeks after first presentation
severity of migraine attacks
Time frame: 1 month after first presentation
severity of migraine attacks
Time frame: 3 months after first presentation
severity of migraine attacks
Time frame: 6 months after first presentation
duration of migraine attacks
Time frame: 1 month after first presentation
duration of migraine attacks
Time frame: 3 months after first presentation
duration of migraine attacks
Time frame: 6 months after first presentation
frequency of migraine attacks
Time frame: 1 month after first presentation
frequency of migraine attacks
Time frame: 3 months after first presentation
frequency of migraine attacks
Time frame: 6 months after first presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohammad khodashenas roudsari, M.D. study chair
assistant proffessor of internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cupping and serkangabin syrup and conventional migraine drug treatment in people with Migraine Headache, run by Birjand University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of migraine attacks per week (time frame: 2 weeks after first presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.