Comparison of TCM and Laxatives for Adults With Chronic Constipation

Chronic Constipation Clinical Trial

Official title:

Comparison of Chinese Herbal Formula and Lactulose for Adults With Chronic Constipation-a Randomized ,Double-Blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745147
• Other study ID #: 200803029M
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2008
• Last updated: May 3, 2010
• Start date: July 2008
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Douliou	Yun-Lin

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Lembo A, Camilleri M. Chronic constipation. N Engl J Med. 2003 Oct 2;349(14):1360-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of spontaneous bowel movement		every week	No
Secondary	amount of rescue laxative use		every week	No
Secondary	stool consistency		every week	No
Secondary	stool amount		every week	No
Secondary	global assessment of efficacy		2 months	No
Secondary	safety evaluation		every week	Yes
Secondary	frequency of enema/suppository use/digital maneuver		every week	No
Secondary	medical cost per spontaneous bowel movement		every week	No