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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: Chinese Herb: CCH1

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Yun-Lin, Taiwan, 640
    • National Taiwan University Yun-Lin Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Chinese Herb (CCH1)	Drug: Chinese Herb: CCH1; 1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation
PLACEBO_COMPARATOR: B; Starch powder as placebo	Drug: Chinese Herb: CCH1; 1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
frequency of spontaneous bowel movement	every week
amount of rescue laxative use	every week
frequency of enema/digital maneuver every week	every week

Secondary Outcome Measures

Outcome Measure	Time Frame
stool consistency	every week
stool amount	every week
efficacy of treatment evaluated by care-giver	2 month
evaluation of safety	every week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chien-Hsun Huang, MD, National Taiwan University Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ACTUAL): February 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: July 18, 2006
• First Submitted That Met QC Criteria: July 18, 2006
• First Posted (ESTIMATE): July 20, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): August 18, 2008
• Last Update Submitted That Met QC Criteria: August 14, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Constipation;; Chinese herb;; Long-term care;; Integrative Chinese Medicine and Western Medicine
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 941216