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Comparison of TCM and Laxatives for Adults With Chronic Constipation

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00745147
First received: August 31, 2008
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

The purpose of the study is to compare the therapeutic efficacy, safety, cost-effectiveness and maintenance effect between Chinese herbal formula and lactulose on chronic constipation in long-term care.


Condition Intervention Phase
Chronic Constipation
Drug: Chinese herbal formula (CCH1)
Drug: Duphalac
Phase 3

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: Comparison of Chinese Herbal Formula and Lactulose for Adults With Chronic Constipation-a Randomized ,Double-Blind, Controlled Trial

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • amount of rescue laxative use [ Time Frame: every week ] [ Designated as safety issue: No ]
  • stool consistency [ Time Frame: every week ] [ Designated as safety issue: No ]
  • stool amount [ Time Frame: every week ] [ Designated as safety issue: No ]
  • global assessment of efficacy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • safety evaluation [ Time Frame: every week ] [ Designated as safety issue: Yes ]
  • frequency of enema/suppository use/digital maneuver [ Time Frame: every week ] [ Designated as safety issue: No ]
  • medical cost per spontaneous bowel movement [ Time Frame: every week ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Chinese herbal formula + Placebo of duphalac
Drug: Chinese herbal formula (CCH1)
initial dose of 1.5/3.0/4.5gm herbal powder with 15/30/45ml placebo of duphalac, respectively, per day for mild/moderate/severe constipation, then titrated
Other Name: TCM
Active Comparator: B
Duphalac + Placebo of Chinese herbal formula
Drug: Duphalac
initial dose of 15/30/45ml duphalac with 1.5/3.0/4.5gm placebo of herbal powder, respectively, per day for mild/moderate/severe constipation, then titrated
Other Name: Laxative

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 of the TM/CAM products and practices.

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 care quality, decreasing the need of enema or digital maneuver, minimizing the dosage of rescue 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
  • the one who meet any one of the following three criteria: 1.RomeIII criteria; 2.at least once a week of enema/suppository use/digital maneuver in past three months; 3.laxative use in more than half time of last three months

Exclusion Criteria:

  • known severe 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
  • neuromuscular dystrophy or spinal cord injury induced constipation
  • history of drug abuser
  • unstable psychiatric disorders
  • women who are pregnant, as determined by a urine pregnancy test
  • use of an investigational drug (within 30days prior to enrolled)
  • known allergies to the component of study medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745147

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

Publications:
Responsible Party: Chien-Hsun Huang, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00745147     History of Changes
Other Study ID Numbers: 200803029M
Study First Received: August 31, 2008
Last Updated: May 3, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
constipation
traditional Chinese medicine
Chinese herbal formula
lactulose
cost-effective
long-term care

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive
Lactulose
Laxatives
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014