NCT01274793

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2011

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

5.1 years

First QC Date

January 11, 2011

Last Update Submit

March 17, 2015

Conditions

Functional ConstipationFunctional Diarrhea

Keywords

functional constipationfunctional diarrheaacupuncture

Outcome Measures

Primary Outcomes (1)

  • acupuncture benefits functional constipation

    5 years

Study Arms (3)

Mosapride

ACTIVE COMPARATOR

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

Low-dose acupuncture

EXPERIMENTAL

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

Device: Low-dose acupuncture

High-dose acupuncture

EXPERIMENTAL

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

Device: High-dose acupuncture

Interventions

Mosapride Citrate tabletDRUG

Orally administered 5 mg mosapride citrate tablet s three times a day for 4 continuous weeks if no severe adverse effects were found.

Also known as: GASMOTIN
Mosapride
Low-dose acupunctureDEVICE

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

Low-dose acupuncture
High-dose acupunctureDEVICE

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

High-dose acupuncture

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • function constipation function diarrhea

You may not qualify if:

  • not function constipation not function diarrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 35027932DERIVED

  • 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.

    PMID: 24143917DERIVED

MeSH Terms

Interventions

mosaprideAcupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Guangying Huang, doctor

    institute of integrated traditional chinese and western medicine，Tongji meidical college,HUST

    STUDY DIRECTOR

Central Study Contacts

Guangying Huang, doctor

CONTACT

86-27-83663266gyhuang@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 12, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

CN(1)