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

Huazhong University of Science and Technology

Status and phase

Unknown

Phase 1

Conditions

Functional Constipation

Functional Diarrhea

Treatments

Drug: Mosapride Citrate tablet

Device: High-dose acupuncture

Device: Low-dose acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT01274793

2011CB505203

Details and patient eligibility

About

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

Full description

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

Enrollment

240 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

function constipation function diarrhea

Exclusion criteria

not function constipation not function diarrhea

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

240 participants in 3 patient groups

Mosapride

Active Comparator group

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.

Treatment:

Drug: Mosapride Citrate tablet

Low-dose acupuncture

Experimental group

Description:

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

Treatment:

Device: Low-dose acupuncture

High-dose acupuncture

Experimental group

Description:

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