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Electroacupuncture for the Treatment of Functional Constipation

Sponsor
Huazhong University of Science and Technology (Other)
Overall Status
Unknown status
CT.gov ID
NCT01781897
Collaborator
(none)
243
Enrollment
3
Locations
3
Arms
33.9
Duration (Months)
81
Patients Per Site
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of electroacupuncture on functional constipation.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study will supply significant evidence for using acupuncture to treat functional constipation(FC), and will help us to identify whether it is a therapeutic effect rather than a placebo effect.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
243 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation
Study Start Date :
Feb 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: mosapride

mosapride

Drug: mosapride
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Other Names:
  • GASMOTIN

    		•
    Experimental: Electro-acupuncture

    Electro-acupuncture

    Device: acupuncture
    sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)
    Other Names:
  • Park true/sham devices

    		•
    Sham Comparator: mosapride + sham acupuncture

    mosapride + sham acupuncture

    Device: acupuncture
    sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)
    Other Names:
  • Park true/sham devices

    • Drug: mosapride
    Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
    Other Names:
  • GASMOTIN

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of defecation per week [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • functional constipation according to the Roman Ⅲ standard;

    • aged between 18 and 65 years old

    Exclusion criteria:

    • unconsciousness, psychosis or can't express subjective symptoms;

    • pregnant women or women in lactation period;

    • serious diseases of the heart, liver, kidney, and others;

    • bleeding disorders.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of Huazhong University of Science and Technology Wuhan Hubei China 430000
    2 Hubei Provincial Hospital of TCM Wuhan Hubei China 430000
    3 Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China 430030

    Sponsors and Collaborators

    • Huazhong University of Science and Technology

    Investigators

    • Principal Investigator: Xiaohu Xu, Doctor, HUST(Huazhong University of Science and Technology) Hospital
    • Principal Investigator: Feng Hu, Master, Hubei Hospital of Traditional Chinese Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guangying Huang, professor, Huazhong University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT01781897
    Other Study ID Numbers:
    • 2011CB505203-1
    First Posted:
    Feb 1, 2013
    Last Update Posted:
    Mar 19, 2015
    Last Verified:
    Apr 1, 2014
    Keywords provided by Guangying Huang, professor, Huazhong University of Science and Technology
    acupuncture
    electro-acupuncture
    Additional relevant MeSH terms:
    Constipation
    Mosapride

    Study Results

    No Results Posted as of Mar 19, 2015