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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
20-herb formulation
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

      1. Improvement with defecation
      2. Onset associated with change in frequency of stool
      3. 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).

Sites / Locations

  • Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

20-herb formulation

Placebo

Arm Description

Active herb

Placebo herb formulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
SF-36
Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.
IBS-QoL
Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.

Full Information

First Posted
March 28, 2010
Last Updated
February 25, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
Chinese University of Hong Kong, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03300804
Brief Title
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)
Acronym
TCM-IBS
Official Title
Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
Chinese University of Hong Kong, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20-herb formulation
Arm Type
Active Comparator
Arm Description
Active herb
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo herb formulation
Intervention Type
Drug
Intervention Name(s)
20-herb formulation
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo herb formulation
Primary Outcome Measure Information:
Title
Global IBS symptom improvement
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Bowel Symptom Scale (BSS):
Description
The Bowel Symptom Scale will be used to assess changes in individual IBS and global IBS symptoms during the course of illness.
Time Frame
8 weeks
Title
SF-36
Description
Quality of Life generic (SF-36), will be used for assessment of quality of life in response to treatment.
Time Frame
8 weeks
Title
IBS-QoL
Description
Disease-specific (IBS-QoL) will be used for assessment of quality of life in response to treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Berman, MD
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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