NCT00745147

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 4, 2010

Status Verified

April 1, 2010

Enrollment Period

1.3 years

First QC Date

August 31, 2008

Last Update Submit

May 3, 2010

Conditions

Chronic Constipation

Keywords

constipationtraditional Chinese medicineChinese herbal formulalactulosecost-effectivelong-term care

Outcome Measures

Primary Outcomes (1)

  • frequency of spontaneous bowel movement

    every week

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Chinese herbal formula + Placebo of duphalac

Drug: Chinese herbal formula (CCH1)

B

ACTIVE COMPARATOR

Duphalac + Placebo of Chinese herbal formula

Drug: Duphalac

Interventions

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

Also known as: TCM
A
DuphalacDRUG

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

Also known as: Laxative
B

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, Yun-Lin, 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: 14523145BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

LactuloseLaxatives

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsGastrointestinal AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Chien-Hsun Huang, MD, MSc

    National Taiwan University Hospital, Yun-Lin Branch

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2008

First Posted

September 3, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2009

Study Completion

April 1, 2010

Last Updated

May 4, 2010

Record last verified: 2010-04

Locations

TW(1)