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

NCT03300804 | Completed Phase 2 DMC

• 2 other identifiers: HP-000412361U19AT003266-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Keywords

IBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Bowel Symptom Scale (BSS):

  8 weeks

• SF-36

  8 weeks

• IBS-QoL

  8 weeks

Study Arms (2)

20-herb formulation

ACTIVE COMPARATOR

Active herb

Drug: 20-herb formulation

Placebo

PLACEBO COMPARATOR

Placebo herb formulation

Drug: Placebo

Interventions

20-herb formulation 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

20-herb formulation

Placebo DRUG

Placebo herb formulation

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Chinese University of Hong Kong: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

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

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Brian M Berman, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research Center for Integrative Medicine, University of Maryland

Study Record Dates

• First Submitted: March 28, 2010
• First Posted: October 4, 2017
• Study Start: May 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)