Clinical trial NCT03300804: Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome (TCM- IBS)
Official title: Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-10-04
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Global IBS symptom improvement
timeFrame: 8 weeks
Secondary outcomes:
measure: The Bowel Symptom Scale (BSS):
timeFrame: 8 weeks
measure: SF-36
timeFrame: 8 weeks
measure: IBS-QoL
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Medical Gastroenterelogy Clinic Of the Prince Of Wales, Chinese University of Hong Kong
Study officials:
affiliation: University of Maryland
name: Brian M Berman, MD
role: PRINCIPAL_INVESTIGATOR
References: