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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: 20-herb formulation; Drug: Placebo

• Registration Number: NCT03300804
• Lead Sponsor: University of Maryland, Baltimore

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:

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2010-03-28
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-04
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20-herb formulation	20-herb formulation	Active herb
Placebo	Placebo	Placebo herb formulation

Primary Outcome Measures

Name	Time	Method
Global IBS symptom improvement	8 weeks	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

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

Trial Locations

Locations (1)

Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong