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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)

NCT ID: NCT00153751

Last Updated: 2008-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-05-31

Brief Summary

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To test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with IBS.

Detailed Description

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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.

Conditions

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Colonic Diseases, Functional

Keywords

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Traditional Chinese Medicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Traditional Chinese Medicine

They are Common peony root, other herbs.

Group Type EXPERIMENTAL

Traditional Chinese Medicine

Intervention Type DRUG

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.

Holopon

Holopon

Group Type ACTIVE_COMPARATOR

Holopon

Intervention Type DRUG

holopon

placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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Traditional Chinese Medicine

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

Holopon

holopon

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Other Intervention Names

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TCM Western Medicine dummy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chinese University of Hong Kong

Principal Investigators

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Joseph JY Sung, MD

Role: PRINCIPAL_INVESTIGATOR

CUHK

Locations

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Li Ka Shing Specialist Clinic, Prince of Wales Hospital

Hong Kong (sar), , China

Site Status

Countries

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China

Other Identifiers

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JC_IBS

Identifier Type: -

Identifier Source: org_study_id