Clinical trial NCT00354575: Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Study on the Efficacy and Safety of Traditional Chinese Medicines for Chronic Constipation Residents in Long-Term Care Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Constipation;
Chinese herb;
Long-term care;
Integrative Chinese Medicine and Western Medicine;
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-07-20
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to improve the problem of constipation and increase the quality of long-term care by the regimen of Chinese herb prescribed by professional doctors of 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. According to some surveys, constipation affects approximately 50% to 73% of nursing home residents. 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. Therefore constipation was labeled as "the neglected symptoms".

There is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for constipation. Contrarily, they had abundant clinical experiences and medical records for constipation in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices. The aim of our study is to improve the problem of constipation and increase the quality of long-term care by the regimen of Chinese herb prescribed by professional doctors of Chinese medicine.

The study will be performed under randomized, double-blind, placebo controlled, parallel design. The object of this study is the residents in nursing homes. After intake of Chinese herb, improving constipation and life quality, decreasing the frequency of enema or digital maneuver, minimizing the dosage of laxatives and saving the medical expenditure will be expected.

Eligibility criteria: Inclusion Criteria:

* men and non-pregnant women who are at least 20 years of age;
* patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication
* residents in long-term care units who meet one of the following criteria in past one month: 1. MgO \>= 1 tab tid 2.Dulcolax \>=1 tab qd 3.concurrent use of at least two categories of laxatives 4.at least once a week of enema 5.less than three times a week of bowel movement

Exclusion Criteria:

* known renal or hepatic insufficiency;
* known colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction;
* unknown cause of gastrointestinal bleeding or acute infection
* history of alcohol or drug abuser
* history of psychiatric disorders
* women who are pregnant, as determined by a urine pregnancy test
* use of an investigational drug (within 30days prior to enrollment)
* known allergies to the component of study medication

Primary outcomes:
measure: frequency of spontaneous bowel movement
timeFrame: every week
measure: frequency of enema/digital maneuver every week
timeFrame: every week
measure: amount of rescue laxative use
timeFrame: every week
Secondary outcomes:
measure: stool consistency
timeFrame: every week
measure: stool amount
timeFrame: every week
measure: efficacy of treatment evaluated by care-giver
timeFrame: 2 month
measure: evaluation of safety
timeFrame: every week
Other outcomes:
Locations:
city: Yun-Lin
country: Taiwan
facility: National Taiwan University Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Chien-Hsun Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.