Electroacupuncture for the Treatment of Functional Constipation

Functional Constipation Clinical Trial

Official title:

A Randomized Controlled Trial of Acupuncture to Treat Functional Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01781897
• Other study ID #: 2011CB505203-1
• Status: Recruiting
• Phase: Phase 1
• First received: January 23, 2013
• Last updated: March 17, 2015
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: Huazhong University of Science and Technology
• Contact: Guangying Huang, Doctor
• Phone: 86-027-8366-3266
• Email: Gyhuang[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 243
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• functional constipation according to the Roman ? 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

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

Drug:
• mosapride
Mosapride Citrate tablet(5mg),Dainippon Sumitomo pharmaceutical Co.Ltd,Japan

Locations

Country	Name	City	State
China	Hospital of Huazhong University of Science and Technology	Wuhan	Hubei
China	Hubei Provincial Hospital of TCM	Wuhan	Hubei
China	Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of defecation per week		3 years	No