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

Chronic Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354575
• Other study ID #: 941216
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: August 14, 2008
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Chinese Herb: CCH1
1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation

Locations

Country	Name	City	State
Taiwan	National Taiwan University 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	frequency of spontaneous bowel movement		every week	No
Primary	frequency of enema/digital maneuver every week		every week	No
Primary	amount of rescue laxative use		every week	No
Secondary	stool consistency		every week	No
Secondary	stool amount		every week	No
Secondary	efficacy of treatment evaluated by care-giver		2 month	No
Secondary	evaluation of safety		every week	Yes