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Study of Key Electro-acupuncture Technique on Migraine

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ClinicalTrials.gov Identifier: NCT02580968
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : January 1, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A random controlled trail to evaluate the efficacy of migraine standard electroacupuncture formula, and to analysis the regulation of the intensity-effects and to observe the peripheral NO, CGRP and NF-кB expression level of migraine patients after electroacupuncture treatment.

Condition or disease Intervention/treatment
Migraine Device: electro-acupuncture Drug: flunarizine hydrochloride

Detailed Description:
acupuncture group(group A): treated by acupuncture for 20 days, 1 time per day control group(group B): treated by FlunarizineHydrochloride for 20 days, 1 table per day.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Key Electro-acupuncture Technique on Migraine
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: electro-acupuncture
100hz, 2min. electro-acupoint: LI4(Large Intestine4) with LV3(Liver3).5times a week. lasting for 4 weeks.
Device: electro-acupuncture
electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.
Active Comparator: routin medicine
one tablet of flunarizine hydrochloride tablet per day. lasting for 20days
Drug: flunarizine hydrochloride
flunarizine hydrochloride ,10mg/day,for 20 days。
Other Name: flunarizine


Outcome Measures

Primary Outcome Measures :
  1. Migraine Disability Assessment Questionnaire (MIDAS) [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. The medical outcomes study 36-item short-form health survey(SF-36) [ Time Frame: 20 days ]
  2. peripheral Nitrogen Monoxide(NO) protein expression [ Time Frame: 20 days ]
  3. peripheral Calcitonin gene related peptide(CGRP) protein expression [ Time Frame: 20 days ]
  4. peripheral Nuclear factor-kappa B(NF-кB) protein expression [ Time Frame: 20 days ]
  5. Visual Analogue Scale (VAS) to assess pain [ Time Frame: 20 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • met the diagnostic criteria for migraine; suffering from migraine attacks; migraine attacks for more than 5 days per month, and lasts for 3 months; voluntarily join this study with informed consents.

Exclusion Criteria:

  • other systemic, neurological and psychiatric disorders; headache caused by other diseases; not treatment compliance during the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580968


Contacts
Contact: qinhui fu, Master 86-021-64385700 ext 3534 ff777315@163.com

Locations
China
Longhua Hospital,Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, China, 200032
Contact: Qinhui Fu, MD    +86-21-64385700 ext 3534    ff777315@163.com   
Sub-Investigator: Jun Wang, MD         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Investigators
Study Director: pei jian, master Longhua Hospital
More Information

Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02580968     History of Changes
Other Study ID Numbers: 643857003534
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Electroacupuncture therapy
Migraine
Acupuncture Therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Flunarizine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Vasodilator Agents