Comparison of TCM and Laxatives for Adults With Chronic Constipation - Full Text View

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00745147

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Bowel Movement Constipation

Drug Information available for: Lactulose

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 ]

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 ]

Estimated Enrollment:	110
Study Start Date:	July 2008
Estimated Study Completion Date:	March 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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
B: Active Comparator 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

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

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

Contacts

Contact: Chien-Hsun Huang, MD, MSc

886-5-5323911 ext 5104

dtfm29@yahool.com.tw

Locations

Taiwan, Yun-Lin
National Taiwan University Hospital, Yun-Lin Branch	Recruiting
Douliou, Yun-Lin, Taiwan, 640
Contact: Chien-Hsun Huang, MD, MSc 886-5-5323911 ext 5104 dtfm29@yahoo.com.tw

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:

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

Responsible Party:	National Taiwan University Hospital ( Chien-Hsun Huang )
Study ID Numbers:	200803029M
Study First Received:	August 31, 2008
Last Updated:	January 3, 2010
ClinicalTrials.gov Identifier:	NCT00745147 History of Changes
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:

Signs and Symptoms
Laxatives
Signs and Symptoms, Digestive
Therapeutic Uses
Gastrointestinal Agents

Constipation
Cathartics
Pharmacologic Actions
Lactulose

ClinicalTrials.gov processed this record on February 08, 2010