Comparison of TCM and Laxatives for Adults With Chronic Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00745147
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : May 4, 2010
Information provided by:
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: Chinese herbal formula (CCH1) Drug: Duphalac Phase 3

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  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Chinese Herbal Formula and Lactulose for Adults With Chronic Constipation-a Randomized ,Double-Blind, Controlled Trial
Study Start Date : July 2008
Actual Primary Completion Date : October 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Lactulose

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 Name: 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 Name: Laxative

Primary Outcome Measures :
  1. frequency of spontaneous bowel movement [ Time Frame: every week ]

Secondary Outcome Measures :
  1. amount of rescue laxative use [ Time Frame: every week ]
  2. stool consistency [ Time Frame: every week ]
  3. stool amount [ Time Frame: every week ]
  4. global assessment of efficacy [ Time Frame: 2 months ]
  5. safety evaluation [ Time Frame: every week ]
  6. frequency of enema/suppository use/digital maneuver [ Time Frame: every week ]
  7. medical cost per spontaneous bowel movement [ Time Frame: every week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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; 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00745147

National Taiwan University Hospital, Yun-Lin Branch
Douliou, Yun-Lin, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Chien-Hsun Huang, MD, MSc National Taiwan University Hospital, Yun-Lin Branch

Responsible Party: Chien-Hsun Huang, National Taiwan University Hospital Identifier: NCT00745147     History of Changes
Other Study ID Numbers: 200803029M
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: April 2010

Keywords provided by National Taiwan University Hospital:
traditional Chinese medicine
Chinese herbal formula
long-term care

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Agents