Electroacupuncture for the Treatment of Functional Constipation

NCT ID: NCT01781897

Last Updated: 2015-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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This study will supply significant evidence for using acupuncture to treat functional constipation(FC), and will help us to identify whether it is a therapeutic effect rather than a placebo effect.

Conditions

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Functional Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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mosapride

mosapride

Group Type ACTIVE_COMPARATOR

mosapride

Intervention Type DRUG

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

Electro-acupuncture

Electro-acupuncture

Group Type EXPERIMENTAL

acupuncture

Intervention Type DEVICE

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

mosapride + sham acupuncture

mosapride + sham acupuncture

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type DEVICE

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

mosapride

Intervention Type DRUG

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

Interventions

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acupuncture

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

Intervention Type DEVICE

mosapride

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

Intervention Type DRUG

Other Intervention Names

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Park true/sham devices GASMOTIN

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Guangying Huang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaohu Xu, Doctor

Role: PRINCIPAL_INVESTIGATOR

HUST(Huazhong University of Science and Technology) Hospital

Feng Hu, Master

Role: PRINCIPAL_INVESTIGATOR

Hubei Hospital of Traditional Chinese Medicine

Locations

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Hospital of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Hubei Provincial Hospital of TCM

Wuhan, Hubei, China

Site Status RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guangying Huang, Doctor

Role: CONTACT

86-027-8366-3266

Facility Contacts

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Jing Gui, Master

Role: primary

+8615327285070

Feng Hu, Doctor

Role: primary

+8613469974981

Guangying Huang, doctor

Role: primary

86-027-8366-3266

Other Identifiers

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2011CB505203-1

Identifier Type: -

Identifier Source: org_study_id

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