Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units

NCT ID: NCT00354575

Last Updated: 2008-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-06-30

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.

Conditions

Chronic Constipation

Keywords

Constipation; Chinese herb; Long-term care; Integrative Chinese Medicine and Western Medicine;

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Chinese Herb (CCH1)

Group Type: EXPERIMENTAL

Chinese Herb: CCH1

Intervention Type: DRUG

1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation

B

Starch powder as placebo

Group Type: PLACEBO_COMPARATOR

Chinese Herb: CCH1

Intervention Type: DRUG

1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation

Interventions

Chinese Herb: CCH1

1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

Principal Investigators

Chien-Hsun Huang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Yun-Lin Branch

Douliu, , Taiwan

Countries

Taiwan

References

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

Reference Type: BACKGROUND

PMID: 14523145 (View on PubMed)

Other Identifiers

941216

Identifier Type: -

Identifier Source: org_study_id