Comparison of TCM and Laxatives for Adults With Chronic Constipation

NCT ID: NCT00745147

Last Updated: 2010-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-04-30

Brief Summary

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.

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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Chinese herbal formula + Placebo of duphalac

Group Type: EXPERIMENTAL

Chinese herbal formula (CCH1)

Intervention Type: 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

B

Duphalac + Placebo of Chinese herbal formula

Group Type: ACTIVE_COMPARATOR

Duphalac

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

TCM; Laxative

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Hospital

Principal Investigators

Chien-Hsun Huang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital, Yun-Lin Branch

Locations

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Yun-Lin, Taiwan

Countries

Taiwan

References

Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. doi: 10.1056/NEJMra020995. No abstract available.

Reference Type: BACKGROUND

PMID: 14523145 (View on PubMed)

Other Identifiers

200803029M

Identifier Type: -

Identifier Source: org_study_id