Electroacupuncture for the Treatment of Functional Constipation

March 17, 2015 updated by: Guangying Huang, Huazhong University of Science and Technology

A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

243

Phase

  • Phase 1

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

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Mingmin Zhang, Doctor
        • Principal Investigator:
          • Cuihong Zheng, Doctor
        • Principal Investigator:
          • Xiaohu Xu, Doctor
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Hospital of Huazhong University of Science and Technology
        • Contact:
        • Principal Investigator:
          • Jing Gui, Master
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Hubei Provincial Hospital of TCM
        • Contact:
        • Principal Investigator:
          • Feng Hu, Doctor

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mosapride
Drug: mosapride
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Other Names:
  • GASMOTIN
Experimental: 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
Drug: mosapride
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Other Names:
  • GASMOTIN
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of defecation per week
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

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 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

February 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011CB505203-1

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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