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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Chinese herbal formula + Placebo of duphalac |
|
| B | Active Comparator | Duphalac + Placebo of Chinese herbal formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese herbal formula (CCH1) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of spontaneous bowel movement | every week |
| Measure | Description | Time Frame |
|---|---|---|
| amount of rescue laxative use | every week | |
| stool consistency | every week | |
| stool amount |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chien-Hsun Huang, MD, MSc | National Taiwan University Hospital, Yun-Lin Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital, Yun-Lin Branch | Douliu | Yun-Lin | 640 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14523145 | Background | Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| D054368 | Laxatives |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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|
| Duphalac | Drug | 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 |
|
|
| every week |
| global assessment of efficacy | 2 months |
| safety evaluation | every week |
| frequency of enema/suppository use/digital maneuver | every week |
| medical cost per spontaneous bowel movement | every week |
| D000073893 |
| Sugars |
| D005765 | Gastrointestinal Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |