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Acupuncture for Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00746200
First received: August 31, 2008
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Constipation
 Procedure: (electro)acupuncture
Procedure: sham acupuncture
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • score of questionnaire of constipation symptoms [ Time Frame: every month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • score of questionnaire of quality of life [ Time Frame: every month ] [ Designated as safety issue: No ]
  • amount of laxative use [ Time Frame: every week ] [ Designated as safety issue: No ]
  • frequency of enema/suppository use/digital maneuver [ Time Frame: every week ] [ Designated as safety issue: No ]
  • stool amount [ Time Frame: every week ] [ Designated as safety issue: No ]
  • stool consistency [ Time Frame: every week ] [ Designated as safety issue: No ]
  • overall efficacy [ Time Frame: 2 month ] [ Designated as safety issue: No ]
  • safety (adverse event) [ Time Frame: every week ] [ Designated as safety issue: Yes ]
  • frequency of spontaneous bowel movement [ Time Frame: every week ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Procedure: (electro)acupuncture
Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
Other Name: electroacupuncture
Sham Comparator: S Procedure: sham acupuncture
Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds
Other Name: Sham acupuncture

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746200

Locations
Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chien-Hsun Huang, MD, MSc National Taiwan University Hospital, Yun-Lin Branch
  More Information

Publications:

Responsible Party: Chien-Hsun Huang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00746200     History of Changes
Other Study ID Numbers: 200801047R
Study First Received: August 31, 2008
Last Updated: May 10, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
chronic constipation
electroacupuncture
randomized controlled trial

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013