Comparison of TCM and Laxatives for Adults With Chronic Constipation

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Constipation
• Intervention / Treatment: Drug: Chinese herbal formula (CCH1); Drug: Duphalac

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Yun-Lin
    • Douliou, Yun-Lin, Taiwan, 640
      • National Taiwan University Hospital, Yun-Lin branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Chinese herbal formula + Placebo of duphalac	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; Other Names: TCM
Active Comparator: B; Duphalac + Placebo of Chinese herbal formula	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; Other Names: Laxative

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
frequency of spontaneous bowel movement	every week

Secondary Outcome Measures

Outcome Measure	Time Frame
amount of rescue laxative use	every week
stool consistency	every week
stool amount	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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chien-Hsun Huang, MD, MSc, National Taiwan University Hospital, Yun-Lin branch

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 31, 2008
• First Submitted That Met QC Criteria: August 31, 2008
• First Posted (Estimate): September 3, 2008

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Chinese herbal formula; traditional Chinese medicine; constipation; cost-effective; lactulose; long-term care
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Gastrointestinal Agents; Lactulose; Laxatives
• Other Study ID Numbers: 200803029M