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

NCT ID: NCT03300804

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-06-30

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

20-herb formulation

Active herb

Group Type: ACTIVE_COMPARATOR

20-herb formulation

Intervention Type: DRUG

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

Placebo herb formulation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo herb formulation

Interventions

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

Intervention Type: DRUG

Placebo

Placebo herb formulation

Intervention Type: DRUG

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:

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Brian Berman

Director of Research Center for Integrative Medicine, University of Maryland

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian M Berman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

1U19AT003266-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00041236

Identifier Type: -

Identifier Source: org_study_id