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Electroacupuncture for the Treatment of Functional Constipation

Primary Purpose

Functional Constipation

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
acupuncture
mosapride
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring acupuncture, electro-acupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of Huazhong University of Science and TechnologyRecruiting
  • Hubei Provincial Hospital of TCMRecruiting
  • Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

mosapride

Electro-acupuncture

mosapride + sham acupuncture

Arm Description

mosapride

Electro-acupuncture

mosapride + sham acupuncture

Outcomes

Primary Outcome Measures

number of defecation per week

Secondary Outcome Measures

Full Information

First Posted
January 23, 2013
Last Updated
March 17, 2015
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01781897
Brief Title
Electroacupuncture for the Treatment of Functional Constipation
Official Title
A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
Keywords
acupuncture, electro-acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
243 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mosapride
Arm Type
Active Comparator
Arm Description
mosapride
Arm Title
Electro-acupuncture
Arm Type
Experimental
Arm Description
Electro-acupuncture
Arm Title
mosapride + sham acupuncture
Arm Type
Sham Comparator
Arm Description
mosapride + sham acupuncture
Intervention Type
Device
Intervention Name(s)
acupuncture
Other Intervention Name(s)
Park true/sham devices
Intervention Description
sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)
Intervention Type
Drug
Intervention Name(s)
mosapride
Other Intervention Name(s)
GASMOTIN
Intervention Description
Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
Primary Outcome Measure Information:
Title
number of defecation per week
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangying Huang, Doctor
Phone
86-027-8366-3266
Email
Gyhuang@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohu Xu, Doctor
Organizational Affiliation
HUST(Huazhong University of Science and Technology) Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Feng Hu, Master
Organizational Affiliation
Hubei Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Gui, Master
Phone
+8615327285070
Email
841946472@qq.com
First Name & Middle Initial & Last Name & Degree
Jing Gui, Master
Facility Name
Hubei Provincial Hospital of TCM
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Hu, Doctor
Phone
+8613469974981
Email
351552735@qq.com
First Name & Middle Initial & Last Name & Degree
Feng Hu, Doctor
Facility Name
Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangying Huang, doctor
Phone
86-027-8366-3266
Email
Gyhuang@tjh.tjmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Mingmin Zhang, Doctor
First Name & Middle Initial & Last Name & Degree
Cuihong Zheng, Doctor
First Name & Middle Initial & Last Name & Degree
Xiaohu Xu, Doctor

12. IPD Sharing Statement

Learn more about this trial

Electroacupuncture for the Treatment of Functional Constipation

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