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

Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: 20-herb formulation; Drug: Placebo

Detailed Description

The Specific aims of the project are:

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 20-herb formulation; Active herb	Drug: 20-herb formulation; 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
Placebo Comparator: Placebo; Placebo herb formulation	Drug: Placebo; Placebo herb formulation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Chinese University of Hong Kong; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Brian M Berman, MD, University of Maryland

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 28, 2010
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: IBS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: HP-00041236; 1U19AT003266-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No