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Completed

NCT Number: NCT00746200

Acupuncture for Chronic Constipation

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Taiwan University Hospital, Yun-Lin Branch

Douliu, 640, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(electro)acupuncture

Procedure

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

Other names: electroacupuncture

Sham acupuncture

Procedure

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

Primary outcomes

  1. score of questionnaire of constipation symptoms

    Time frame: every month

Secondary outcomes

  1. score of questionnaire of quality of life

    Time frame: every month

  2. amount of laxative use

    Time frame: every week

  3. frequency of enema/suppository use/digital maneuver

    Time frame: every week

  4. stool amount

    Time frame: every week

  5. stool consistency

    Time frame: every week

  6. overall efficacy

    Time frame: 2 month

  7. safety (adverse event)

    Time frame: every week

  8. frequency of spontaneous bowel movement

    Time frame: every week

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Randomised Controlled Trial of Acupuncture for Patients With Chronic Constipation

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 3, 2008
Registry last updated
May 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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