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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00354575 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
A: Experimental
Chinese Herb (CCH1)
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Drug: Chinese Herb: CCH1
1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation
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B: Placebo Comparator
Starch powder as placebo
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Drug: Chinese Herb: CCH1
1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Taiwan | |
National Taiwan University Yun-Lin Branch | |
Yun-Lin, Taiwan, 640 |
Principal Investigator: | Chien-Hsun Huang, MD | National Taiwan University Hospital |
Responsible Party: | National Taiwan University Hospital ( Chien-Hsun Huang ) |
Study ID Numbers: | 941216 |
Study First Received: | July 18, 2006 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00354575 History of Changes |
Health Authority: | Taiwan: Department of Health |
Constipation; Chinese herb; Long-term care; Integrative Chinese Medicine and Western Medicine; |
Signs and Symptoms Signs and Symptoms, Digestive Constipation Marijuana Abuse |
Signs and Symptoms Signs and Symptoms, Digestive Constipation |