Comparison of TCM & Laxatives for Adults With Chronic Constipation

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00745147
Study type	Interventional
Source	National Taiwan University Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	July 2008
Completion date	April 2010

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05980988` - Effectiveness and Safety of Probiotic in Regulating Chronic Constipation	N/A
Recruiting	`NCT03819062` - Sacral Neuromodulation as Treatment for Chronic Constipation	N/A
Completed	`NCT00730171` - An Open-label, Long-term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT00765882` - Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation	Phase 3
Completed	`NCT00354575` - Effect of Chinese Herb on Chronic Constipation for Residents in Long-Term Care Units	Phase 2
Active, not recruiting	`NCT03119584` - Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation	Phase 4
Completed	`NCT00765999` - An Open-Label, Long-Term Safety Study of Linaclotide in Patients With Chronic Constipation or Irritable Bowel Syndrome With Constipation	Phase 3
Completed	`NCT01793753` - Effect of Propofol on Internal Anal Sphincter Pressure During ARM	N/A
Completed	`NCT00746200` - Acupuncture for Chronic Constipation	Phase 3
Enrolling by invitation	`NCT00671684` - Endoscopic Mucosal Resection (EMR) for Diagnosis of Hirschsprung's Disease	Phase 1/Phase 2
Completed	`NCT00391820` - Evaluate the Safety and Efficacy of a 5-HT4 Agonist in Chronic Constipation (ACCORD Trial)	Phase 2
Completed	`NCT00404040` - Movicol in Childhood Constipation (ProMotion Study)	Phase 2
Completed	`NCT02281630` - Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)	Phase 2
Completed	`NCT00256984` - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS)	Phase 4
Recruiting	`NCT05192317` - Administration of a Natural Molecular Complex in Functional Chronic Constipation	N/A
Active, not recruiting	`NCT05202028` - The Efficacy of Massage and Reflexology Applications in Children With Cerebral Palsy	N/A
Completed	`NCT05734859` - Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation	N/A
Completed	`NCT01007123` - Study of A3309 in Patients With Chronic Idiopathic Constipation	Phase 2
Completed	`NCT00402337` - Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation	Phase 2
Completed	`NCT02961556` - General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of TCM and Laxatives for Adults With Chronic Constipation

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms