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

Primary Purpose

Functional Constipation, Functional Diarrhea

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mosapride Citrate tablet
Low-dose acupuncture
High-dose acupuncture
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 functional constipation, functional diarrhea, acupuncture

Eligibility Criteria

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

Inclusion Criteria:

  • function constipation function diarrhea

Exclusion Criteria:

  • not function constipation not function diarrhea

Sites / Locations

  • 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

Experimental

Arm Label

Mosapride

Low-dose acupuncture

High-dose acupuncture

Arm Description

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.

In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants

In this group,the current was strong enough to reach the patients'tolerance threshold value.

Outcomes

Primary Outcome Measures

acupuncture benefits functional constipation

Secondary Outcome Measures

Full Information

First Posted
January 11, 2011
Last Updated
March 17, 2015
Sponsor
Huazhong University of Science and Technology
Collaborators
The Fifth Hospital of Wuhan, Wuhan Union Hospital, China, Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01274793
Brief Title
Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy
Official Title
Multicentre Randomized Controlled Trial for Quantity-Effect Relationship of Acupuncture With Two-ways Regulation to Treat Functional Enteropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (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
Collaborators
The Fifth Hospital of Wuhan, Wuhan Union Hospital, China, Guangzhou University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
the objective of this study is to investigate the Dose-Effect Relationship of Acupuncture with Two-ways Regulation Effect to Treat Functional Enteropathy
Detailed Description
eligibility criteria: functional constipation,functional diarrhea，irritable bowel syndrome

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation, Functional Diarrhea
Keywords
functional constipation, functional diarrhea, acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mosapride
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low-dose acupuncture
Arm Type
Experimental
Arm Description
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
Arm Title
High-dose acupuncture
Arm Type
Experimental
Arm Description
In this group,the current was strong enough to reach the patients'tolerance threshold value.
Intervention Type
Drug
Intervention Name(s)
Mosapride Citrate tablet
Other Intervention Name(s)
GASMOTIN
Intervention Description
Orally administered 5 mg mosapride citrate tablet s three times a day for 4 continuous weeks if no severe adverse effects were found.
Intervention Type
Device
Intervention Name(s)
Low-dose acupuncture
Intervention Description
In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
Intervention Type
Device
Intervention Name(s)
High-dose acupuncture
Intervention Description
In this group,the current was strong enough to reach the patients'tolerance threshold value.
Primary Outcome Measure Information:
Title
acupuncture benefits functional constipation
Time Frame
5 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: function constipation function diarrhea Exclusion Criteria: not function constipation not function diarrhea
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangying Huang, doctor
Phone
86-27-83663266
Email
gyhuang@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangying Huang, doctor
Organizational Affiliation
institute of integrated traditional chinese and western medicine，Tongji meidical college,HUST
Official's Role
Study Director
Facility Information:
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
Fan Xiong, Doctor
First Name & Middle Initial & Last Name & Degree
Ying Wang, Master
First Name & Middle Initial & Last Name & Degree
Man Tian, Master

12. IPD Sharing Statement

Citations:
PubMed Identifier
35027932
Citation
Xu X, Zhang M, Wu X, Zheng C, Huang G. The Effect of Electroacupuncture Treatment with Different Intensities for Functional Diarrhea: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2022 Jan 4;2022:2564979. doi: 10.1155/2022/2564979. eCollection 2022.
Results Reference
derived
PubMed Identifier
24143917
Citation
Zheng CH, Huang GY, Xu XH, Wang Y, Zhang MM, Wang W, Jing XH, Zhu B. Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial. Trials. 2013 Oct 22;14:344. doi: 10.1186/1745-6215-14-344.
Results Reference
derived

Learn more about this trial

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

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