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

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Unknown status

CT.gov ID

NCT01274793

Collaborator

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

240

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Functional Constipation Functional Diarrhea	Drug: Mosapride Citrate tablet Device: Low-dose acupuncture Device: High-dose acupuncture	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

acupuncture benefits functional constipation [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

function constipation function diarrhea

Exclusion Criteria:

not function constipation not function diarrhea

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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
The Fifth Hospital of Wuhan
Wuhan Union Hospital, China
Guangzhou University of Traditional Chinese Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangying Huang, Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01274793

Other Study ID Numbers:

2011CB505203

First Posted:

Jan 12, 2011

Last Update Posted:

Mar 19, 2015

Last Verified:

Mar 1, 2015

Keywords provided by Guangying Huang, Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Huazhong University of Science and Technology

functional constipation

functional diarrhea

acupuncture

Additional relevant MeSH terms:

Constipation

Diarrhea

Mosapride

Study Results

No Results Posted as of Mar 19, 2015