Chronic Constipation Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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