Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units

NCT00354575 | Completed Phase 2 DMC

• 1 other identifier: 941216
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Constipation

Keywords

Constipation;; Chinese herb;; Long-term care;; Integrative Chinese Medicine and Western Medicine;

Outcome Measures

Primary Outcomes (3)

• frequency of spontaneous bowel movement

  every week

• frequency of enema/digital maneuver every week

  every week

• amount of rescue laxative use

  every week

Secondary Outcomes (4)

• stool consistency

  every week

• stool amount

  every week

• efficacy of treatment evaluated by care-giver

  2 month

• evaluation of safety

  every week

Study Arms (2)

A

EXPERIMENTAL

Chinese Herb (CCH1)

Drug: Chinese Herb: CCH1

B

PLACEBO COMPARATOR

Starch powder as placebo

Drug: Chinese Herb: CCH1

Interventions

Chinese Herb: CCH1 DRUG

1.5/3.0/4.5gm powder per day for mild/moderate/severe constipation

A; B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• residents in long-term care units who meet one of the following criteria in past one month: 1. MgO \>= 1 tab tid 2.Dulcolax \>=1 tab qd 3.concurrent use of at least two categories of laxatives 4.at least once a week of enema 5.less than three times a week of bowel movement

You may not qualify if:

• known 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
• history of alcohol or drug abuser
• history of psychiatric disorders
• women who are pregnant, as determined by a urine pregnancy test
• use of an investigational drug (within 30days prior to enrollment)
• known allergies to the component of study medication

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Yun-Lin Branch

Douliu, 640, Taiwan

Location

Related Publications (1)

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

  PMID: 14523145 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chien-Hsun Huang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 20, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 18, 2008

Record last verified: 2008-07

Locations

TW (1)