The Efficacy of Tradition Chinese Medicine in Patients With Irritable Bowel Syndrome (TCM-IBS)
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome(TCM- IBS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in treating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of IBS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. A methodologically strong trial of a 20-herb formula has shown significant benefit for IBS patients. However, the herbal formulation was inadequately characterized and defined for repeated clinical studies.
Subsequent to complete chemical characterization, a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial will be conducted to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 104 patients aged 18 to 75 with all types of IBS. At each of two dosage levels, 52 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 1:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st dosage level, safety will be assessed prior to using the higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequency of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by dose counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional pharmaceuticals.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Hong Kong (SAR), China, 852
- Li Ka Shing Specialist Clinic, Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All IBS patients attending the Gastroenterology Clinic of the Prince of Wales Hospital of Hong Kong.
- Age 18-75 inclusive
IBS diagnosed by Rome III criteria:
- Recurrent abdominal pain or discomfort at least three days per month in the previous three months
- Symptom onset at least six months prior to diagnosis
Pain or discomfort associated with two or more of the following:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
- Normal colonic evaluation (colonoscopy or barium enema) in past 5 years
- No "global symptom improvement" as rated by patients (see below) at baseline and during the two-week run-in period
- Normal full blood count, liver function test and renal function test.
- Informed written consent for participation into study.
- Ethical approval will be obtained from the Joint CUHK-NTEC Clinical Research Ethics Committee as well as the IRB of UMB.
Exclusion Criteria:
- Past or present history of organic disease of gastrointestinal tract (e.g. colorectal cancer, advanced colonic polyp, celiac disease, inflammatory bowel disease, peptic ulcer and previous gastrointestinal surgery). (Note: those with polyps removed during colonoscopy can be included, as long as no known polyps remained).
- Systemic diseases that cause diarrhea or constipation (e.g. thyroid disease, diabetic neuropathy)
- Lactose intolerance
- Severe liver diseases (e.g. cirrhosis, chronic active hepatitis)
- Renal impairment (serum creatinine level > 150mmol/L)
- Women who are pregnant, lactating or not practicing proper contraception
- Known hypersensitivity to herbal medicine
- Concommitant use of prescription antidepressant medication.
- Current alcoholism and drug abuse
- Current psychiatric illness or dementia
- Fever or severe illness at baseline (week 0).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional Chinese Medicine
Traditional Chinese Medicine 17g herbal extract
|
A herbal extract 17g once daily for 8 weeks for lower dosage, and 34g for higher dosage. The 20-herb formulation are Agastache rugosa,Fraxinus rhynchophylla, Angelica dahurica,Glycyrrhiza uralensis, Artemisia capillaris, Magnolia officinalis, Atractylodes macrocephala,Paeonia lactiflora, Aucklandia lappa, Plantago asiatica,Bupleurum chinense, Phellodendron amurense, Citrus reticulate, Poria cocos, Codonopsis pilosula, Saposhnikovia diraricata, Coix lacryma-jobi, Schisandra chinensis, Coptis chinensis, Zingiber officinale |
|
Placebo Comparator: Traditional Chinese Medicine Placebo
Placebo
|
Placebo once daily for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient reported global symptom improvement, based on this question: "Have you had adequate relief of your symptoms over the last two weeks"? (yes/no)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bowel Symptom Scale (BSS): to assess changes in individual IBS and global IBS symptoms. QoL assessment:one disease-specific (IBS-QoL) and one generic (SF-36), will be used.
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCM-IBS
- 1U19AT003266-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.