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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00354575
First received: July 18, 2006
Last updated: August 14, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Constipation
 Drug: Chinese Herb: CCH1
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • frequency of spontaneous bowel movement [ Time Frame: every week ] [ Designated as safety issue: No ]
  • frequency of enema/digital maneuver every week [ Time Frame: every week ] [ Designated as safety issue: No ]
  • amount of rescue laxative use [ Time Frame: every week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • stool consistency [ Time Frame: every week ] [ Designated as safety issue: No ]
  • stool amount [ Time Frame: every week ] [ Designated as safety issue: No ]
  • efficacy of treatment evaluated by care-giver [ Time Frame: 2 month ] [ Designated as safety issue: No ]
  • evaluation of safety [ Time Frame: every week ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: September 2006
Study Completion Date: June 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354575

Locations
Taiwan
National Taiwan University Yun-Lin Branch
Yun-Lin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chien-Hsun Huang, MD National Taiwan University Hospital
  More Information

Publications:

Responsible Party: Chien-Hsun Huang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00354575     History of Changes
Other Study ID Numbers: 941216
Study First Received: July 18, 2006
Last Updated: August 14, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Constipation;
Chinese herb;
Long-term care;
Integrative Chinese Medicine and Western Medicine;

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013