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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354575
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : August 18, 2008
Sponsor:
Information provided by:
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: Chinese Herb: CCH1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : September 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

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




Primary Outcome Measures :
  1. frequency of spontaneous bowel movement [ Time Frame: every week ]
  2. frequency of enema/digital maneuver every week [ Time Frame: every week ]
  3. amount of rescue laxative use [ Time Frame: every week ]

Secondary Outcome Measures :
  1. stool consistency [ Time Frame: every week ]
  2. stool amount [ Time Frame: every week ]
  3. efficacy of treatment evaluated by care-giver [ Time Frame: 2 month ]
  4. evaluation of safety [ Time Frame: every week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354575


Locations
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Taiwan
National Taiwan University Yun-Lin Branch
Yun-Lin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chien-Hsun Huang, MD National Taiwan University Hospital
Publications:
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Responsible Party: Chien-Hsun Huang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00354575    
Other Study ID Numbers: 941216
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: July 2008
Keywords provided by National Taiwan University Hospital:
Constipation;
Chinese herb;
Long-term care;
Integrative Chinese Medicine and Western Medicine;
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive