Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy

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

Multicentre Randomized Controlled Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy

the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture with Two-ways Regulation Effect to Treat Functional Enteropathy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

eligibility criteria: functional constipation,functional diarrhea，irritable bowel syndrome

Study Type

Interventional

Enrollment (Anticipated)

240

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 Contact

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:
          • Fan Xiong, Doctor
        • Principal Investigator:
          • Ying Wang, Master
        • Principal Investigator:
          • Man Tian, Master

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:

  • function constipation function diarrhea

Exclusion Criteria:

  • not function constipation not function diarrhea

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mosapride
In the control group were orally administered 5 mg mosapride citrate tablet s three times a day for 4 continu ous weeks if no severe adverse effects were found.
Drug: Mosapride Citrate tablet
Orally administered 5 mg mosapride citrate tablet s three times a day for 4 continuous weeks if no severe adverse effects were found.
Other Names:
  • GASMOTIN
Experimental: Low-dose acupuncture
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
Device: Low-dose acupuncture
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
Experimental: High-dose acupuncture
In this group,the current was strong enough to reach the patients'tolerance threshold value.
Device: High-dose acupuncture
In this group,the current was strong enough to reach the patients'tolerance threshold value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acupuncture benefits functional constipation
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Huazhong University of Science and Technology

Collaborators

Wuhan Union Hospital, China
Guangzhou University of Traditional Chinese Medicine
The Fifth Hospital of Wuhan

Investigators

  • Study Director: Guangying Huang, doctor, institute of integrated traditional chinese and western medicine，Tongji meidical college,HUST

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 11, 2011

First Posted (Estimate)

January 12, 2011

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011CB505203

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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