The Efficacy of Tradition Chinese Medicine in Patients With Irritable Bowel Syndrome

NCT00676975 | Completed Phase 2

• 2 other identifiers: TCM-IBS1U19AT003266-01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

To test the efficacy of Traditional Chinese Medicine in relieving symptoms and change of quality of life of patients with Irritable Bowel Syndrome.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel disease; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Patient reported global symptom improvement, based on this question: "Have you had adequate relief of your symptoms over the last two weeks"? (yes/no)

  12 weeks

Secondary Outcomes (1)

• Bowel Symptom Scale (BSS): to assess changes in individual IBS and global IBS symptoms. QoL assessment:one disease-specific (IBS-QoL) and one generic (SF-36), will be used.

  12 weeks

Study Arms (2)

Traditional Chinese Medicine

ACTIVE COMPARATOR

Traditional Chinese Medicine 17g herbal extract

Drug: Traditional Chinese Medicine

Traditional Chinese Medicine Placebo

PLACEBO COMPARATOR

Placebo

Drug: Traditional Chinese Medicine Placebo

Interventions

Traditional Chinese Medicine DRUG

A herbal extract 17g once daily for 8 weeks for lower dosage, and 34g for higher dosage. The 20-herb formulation are Agastache rugosa,Fraxinus rhynchophylla, Angelica dahurica,Glycyrrhiza uralensis, Artemisia capillaris, Magnolia officinalis, Atractylodes macrocephala,Paeonia lactiflora, Aucklandia lappa, Plantago asiatica,Bupleurum chinense, Phellodendron amurense, Citrus reticulate, Poria cocos, Codonopsis pilosula, Saposhnikovia diraricata, Coix lacryma-jobi, Schisandra chinensis, Coptis chinensis, Zingiber officinale

Traditional Chinese Medicine

Traditional Chinese Medicine Placebo DRUG

Placebo once daily for 8 weeks

Traditional Chinese Medicine Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All IBS patients attending the Gastroenterology Clinic of the Prince of Wales Hospital of Hong Kong.
• Age 18-75 inclusive
• IBS diagnosed by Rome III criteria:
• Recurrent abdominal pain or discomfort at least three days per month in the previous three months
• Symptom onset at least six months prior to diagnosis
• Pain or discomfort associated with two or more of the following:
• Improvement with defecation
• Onset associated with a 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 baseline and during the two-week run-in period
• 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 diseases (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 abuse
• Current psychiatric illness or dementia
• Fever or severe illness at baseline (week 0).

Sponsors & Collaborators

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

Study Sites (1)

Li Ka Shing Specialist Clinic, Prince of Wales Hospital

Hong Kong (sar), 852, China

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Francis KL Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 9, 2008
• First Posted: May 13, 2008
• Study Start: May 26, 2008
• Primary Completion: December 30, 2010
• Study Completion: August 30, 2011
• Last Updated: April 25, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)