NCT01781897

Brief Summary

The purpose of this study is to investigate the effect of electroacupuncture on functional constipation.

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
243

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2013

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

January 23, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.8 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

April 1, 2014

Enrollment Period

2.8 years

First QC Date

January 23, 2013

Last Update Submit

March 17, 2015

Conditions

Functional Constipation

Keywords

acupunctureelectro-acupuncture

Outcome Measures

Primary Outcomes (1)

  • number of defecation per week

    3 years

Study Arms (3)

mosapride

ACTIVE COMPARATOR

mosapride

Drug: mosapride

Electro-acupuncture

EXPERIMENTAL

Electro-acupuncture

Device: acupuncture

mosapride + sham acupuncture

SHAM COMPARATOR

mosapride + sham acupuncture

Device: acupunctureDrug: mosapride

Interventions

acupunctureDEVICE

sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)

Also known as: Park true/sham devices
Electro-acupuncturemosapride + sham acupuncture
mosaprideDRUG

Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan

Also known as: GASMOTIN
mosapridemosapride + sham acupuncture

Eligibility Criteria

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

You may qualify if:

  • functional constipation according to the Roman Ⅲ standard;
  • aged between 18 and 65 years old

You may not qualify if:

  • unconsciousness, psychosis or can't express subjective symptoms;
  • pregnant women or women in lactation period;
  • serious diseases of the heart, liver, kidney, and others;
  • bleeding disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Hubei Provincial Hospital of TCM

Wuhan, Hubei, 430000, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapymosapride

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Xiaohu Xu, Doctor

    HUST(Huazhong University of Science and Technology) Hospital

    PRINCIPAL INVESTIGATOR

  • Feng Hu, Master

    Hubei Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guangying Huang, Doctor

CONTACT

86-027-8366-3266Gyhuang@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 23, 2013

First Posted

February 1, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 19, 2015

Record last verified: 2014-04

Locations

CN(3)