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Acupuncture for Chronic Constipation

Primary Purpose

Chronic Constipation

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

(electro)acupuncture

sham acupuncture

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring chronic constipation, electroacupuncture, randomized controlled trial

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

men or non-pregnant women who are at least 20 years old
who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months

Exclusion Criteria:

known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction
unknown cause of gastrointestinal bleeding or acute infection
history of alcohol or drug abuser
women who are pregnant, as determined by a urine pregnancy test
history of adverse reaction to (electro)acupuncture
received herb or acupuncture therapy within one month prior to enrollment

Sites / Locations

National Taiwan University Hospital, Yun-Lin Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

score of questionnaire of constipation symptoms

Secondary Outcome Measures

score of questionnaire of quality of life

amount of laxative use

frequency of enema/suppository use/digital maneuver

stool amount

stool consistency

overall efficacy

safety (adverse event)

frequency of spontaneous bowel movement

Full Information

NCT ID

NCT00746200

First Posted

August 31, 2008

Last Updated

May 10, 2010

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00746200

Brief Title

Acupuncture for Chronic Constipation

Official Title

Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Since there have been few advances for constipation in laxative treatment in the last 50 years, this study is designed to evaluate the efficacy and safety of acupuncture for patients with chronic constipation based on the theory of traditional Chinese Medicine.

Detailed Description

Although many people regard regular defecation as important factor to maintain healthy, constipation is still a common problem in general population. Because the symptoms cause serious impairment of life quality, laxatives are commonly prescribed for people and over prescribing of laxatives is also common. Despite the large sums spent on laxatives, there have been few advances in laxative treatment in the last 50 years and there have been minimal research addressing the problem. Since there is unsatisfactory effect by current pharmacologic therapies and preventive strategies, we look forward to the practice of traditional Chinese medicine, which had abundant clinical experiences and medical records in the past of thousands years ago. Therefore we aim to do the research to create the evidence of acupuncture on the safety, efficacy and quality of life for chronic constipation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Constipation

Keywords

chronic constipation, electroacupuncture, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Sham Comparator

Intervention Type

Procedure

Intervention Name(s)

(electro)acupuncture

Other Intervention Name(s)

electroacupuncture

Intervention Description

Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;

Intervention Type

Procedure

Intervention Name(s)

sham acupuncture

Intervention Description

Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds

Primary Outcome Measure Information:

Title

score of questionnaire of constipation symptoms

Time Frame

every month

Secondary Outcome Measure Information:

Title

score of questionnaire of quality of life

Time Frame

every month

Title

amount of laxative use

Time Frame

every week

Title

frequency of enema/suppository use/digital maneuver

Time Frame

every week

Title

stool amount

Time Frame

every week

Title

stool consistency

Time Frame

every week

Title

overall efficacy

Time Frame

2 month

Title

safety (adverse event)

Time Frame

every week

Title

frequency of spontaneous bowel movement

Time Frame

every week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: men or non-pregnant women who are at least 20 years old who meet any one of the following three criteria: 1.the one who meets RomeIII criteria; 2.at least once a week of enema/suppository in past three months; 3.laxative use in more than half time of last three months Exclusion Criteria: known colorectal cancer, anal abscess, anal fissure, rectocele, inflammatory bowel disease, megacolon or mechanical bowel obstruction unknown cause of gastrointestinal bleeding or acute infection history of alcohol or drug abuser women who are pregnant, as determined by a urine pregnancy test history of adverse reaction to (electro)acupuncture received herb or acupuncture therapy within one month prior to enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chien-Hsun Huang, MD, MSc

Organizational Affiliation

National Taiwan University Hospital, Yun-Lin Branch

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital, Yun-Lin Branch

City

Yun-Lin

ZIP/Postal Code

640

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

14523145

Citation

Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.

Results Reference

background

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Acupuncture for Chronic Constipation

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