Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a 20- herb formulation, as a well characterised extract, is efficacious in treating irritable bowel syndrome (IBS) and also to identify efficacious and safe dosage of the formulation in treating IBS.

Detailed Description
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The Specific aims of the project are: To determine whether a 20- herb formulation improves pain/ discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine. To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment, among 2 dosages. This is determined by relief of symptoms of IBS in a dose escalation, placebo-controlled double- blind randomized clinical trial, in conjunction with indices of safety and tolerability.

Official Title
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Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: 20-herb formulation
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18- 75 All IBS patients attending the Gastroenterology Clinic of the Prince Of Wales Hospital of Hong Kong. IBS diagnosed by Rome III criteria: Recurrent abdominal pain or discomfort at least three days per month in the previous three months Symptoms onset at least six months prior to diagnose Pain or discomfort associated with two or more of the following: Improvement with defecation Onset associated with 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 screening and during the two- week run- in period to baseline 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 disease (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 use Current psychiatric illness or dementia Fever or severe illness at baseline (week 0).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20-herb formulation<br>Active herb | Drug: 20-herb formulation<br>* Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo herb formulation | Drug: Placebo<br>* Placebo herb formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global IBS symptom improvement | The primary endpoint for this study is the efficacy at the 8 week followup visit of the herbal formulations, which is defined by the patient's global assessment of the IBS symptoms. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Bowel Symptom Scale (BSS): | The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness. | 8 weeks | 
| SF-36 | Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment. | 8 weeks | 
| IBS-QoL | Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS