A Phase 2 interventional study of Chinese Herb: CCH1 in Chronic Constipation, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2008-08-18.
Sponsored by National Taiwan University Hospital · Phase 2, Interventional, and Treatment
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 168 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Chinese Herb (CCH1)
Drug: Chinese Herb: CCH1
Starch powder as placebo
Drug: Chinese Herb: CCH1
1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation
frequency of spontaneous bowel movement
Time frame: every week
frequency of enema/digital maneuver every week
Time frame: every week
amount of rescue laxative use
Time frame: every week
stool consistency
Time frame: every week
stool amount
Time frame: every week
efficacy of treatment evaluated by care-giver
Time frame: 2 month
evaluation of safety
Time frame: every week
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital