Cupping and Serkangabin Versus Conventional Migraine Treatment

NCT01476930 | Completed Phase 4 DMC

• 2 other identifiers: n231n231hej
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Headache

Keywords

migraine; prophylactic treatment; cupping; serkangabin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• severity of migraine attacks

  2 weeks after first presentation

• duration of migraine attacks

  2 weeks after first presentation

• severity of migraine attacks

  1 month after first presentation

• severity of migraine attacks

  3 months after first presentation

• severity of migraine attacks

  6 months after first presentation

Study Arms (2)

cupping serkangabin

EXPERIMENTAL

migraine cases treated by cupping and serkangabin syrup

Procedure: cupping and serkangabin syrup

conventional

ACTIVE COMPARATOR

migraine cases treated by conventional drug treatment protocols

Drug: conventional migraine drug treatment

Interventions

cupping and serkangabin syrup PROCEDURE

wet cupping serkangabin syrup

cupping serkangabin

conventional migraine drug treatment DRUG

nortriptyline ,propranolol ,ergotamine , sumatriptan tablets

conventional

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• migraine headache with or without aura

You may not qualify if:

• 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

Sponsors & Collaborators

• Birjand University of Medical Sciences: lead

Study Sites (1)

Birjand University of Medical Sciences,Valiasr Hospital

Birjand, South Khorasan Province, 9714815395, Iran

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• mohammad khodashenas roudsari, M.D.

  assistant proffessor of internal medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: November 22, 2011
• Study Start: June 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2011
• Last Updated: November 24, 2014

Record last verified: 2014-11

Locations

IR (1)