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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00746200
Other study ID # 200801047R
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2008
Last updated May 10, 2010
Start date October 2008
Est. completion date May 2010

Study information

Verified date May 2010
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 2010
Est. primary completion date April 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
(electro)acupuncture
Frequency of electrostimulation: 15Hz; Duration of electrostimulation: 20min;
sham acupuncture
Superficial acupuncture needle stimulation at non-acupoints with TENS applied for seconds

Locations

Country Name City State
Taiwan National Taiwan University Hospital, Yun-Lin Branch Yun-Lin

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary score of questionnaire of constipation symptoms every month No
Secondary score of questionnaire of quality of life every month No
Secondary amount of laxative use every week No
Secondary frequency of enema/suppository use/digital maneuver every week No
Secondary stool amount every week No
Secondary stool consistency every week No
Secondary overall efficacy 2 month No
Secondary safety (adverse event) every week Yes
Secondary frequency of spontaneous bowel movement every week No
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