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The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)

Primary Purpose

Colonic Diseases, Functional

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Traditional Chinese Medicine
Holopon
placebo
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Diseases, Functional focused on measuring Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study. IBS is diagnosed by Rome II criteria [Thompson et al. Gut 2000]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period Informed written consent for participation into study. Ethical approval will be obtained from the Clinical Research Ethics Committee of the University

Sites / Locations

  • Li Ka Shing Specialist Clinic, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Traditional Chinese Medicine

Holopon

placebo

Arm Description

They are Common peony root, other herbs.

Holopon

Placebo

Outcomes

Primary Outcome Measures

The global assessment of IBS symptom by patients.

Secondary Outcome Measures

Individual IBS symptoms and QOL assessment

Full Information

First Posted
September 8, 2005
Last Updated
May 9, 2008
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00153751
Brief Title
The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Official Title
Clinical Study to Test the Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With IBS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.
Detailed Description
Irritable bowel syndrome (IBS) is a diagnosis in Western Medicine characterized by recurrent abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation. Epidemiological studies showed that 14% of males and 27% of females in the US (white) have symptoms of IBS. In Hong Kong, our survey reported a similar prevalence of this condition among Chinese (13% in males and 21% in females). IBS is one of the most common conditions leading to seeking of medical care. Treatment for IBS has so far been unsatisfactory. Numerous medications have been proposed for IBS; however, none is convincingly effective. A review and critique of published drug trials for IBS from 1966 to 1988 concluded that there was no proof that any western medicine is effective for all IBS patients. With the unsatisfactory treatment response of western medicine, many turned to alternative treatment modalities for IBS. Traditional Chinese medicine is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions has been known for centuries. However, there is a lack of convincing clinical data demonstrating the effectiveness of Chinese medicine in this condition. In this study, we sought to determine the efficacy of herbal medicine in relieving symptoms and quality of life of patients with IBS. This is a prospective randomized, double-blinded double placebo-controlled study in patients with non-constipation type IBS. Patients will be randomized to receive either one of three treatment arms: 1. herbal medicine (HM) + placebo western medicine (WM), 2. WM + placebo HM and 3. placebo HM + placebo WH. Each patient will go through an 8-week period of randomized double-blind treatment with either HW, WM or placebo and followed by an 8-week of observation period. The IBS symptom and quality of life will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases, Functional
Keywords
Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Chinese Medicine
Arm Type
Experimental
Arm Description
They are Common peony root, other herbs.
Arm Title
Holopon
Arm Type
Active Comparator
Arm Description
Holopon
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Traditional Chinese Medicine
Other Intervention Name(s)
TCM
Intervention Description
They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.
Intervention Type
Drug
Intervention Name(s)
Holopon
Other Intervention Name(s)
Western Medicine
Intervention Description
holopon
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
dummy
Intervention Description
placebo
Primary Outcome Measure Information:
Title
The global assessment of IBS symptom by patients.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Individual IBS symptoms and QOL assessment
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients (aged 18-65) attending the Gastroenterology Clinic of the Prince of Wales Hospital or Hong Kong Baptist University Chinese Medicine clinics for symptoms of IBS will be enrolled in the study. IBS is diagnosed by Rome II criteria [Thompson et al. Gut 2000]: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool Normal colonic evaluation (colonoscopy or barium enema) in recent 5 years Mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period Informed written consent for participation into study. Ethical approval will be obtained from the Clinical Research Ethics Committee of the University
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph JY Sung, MD
Organizational Affiliation
CUHK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Ka Shing Specialist Clinic, Prince of Wales Hospital
City
Hong Kong (SAR)
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)

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