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Clinical Trials/ACTRN12609000558224
ACTRN12609000558224
Completed
Phase 2

A double blind randomised placebo controlled clinical trial testing the effectiveness of a Chinese herbal medicine extract formulation for constipation-predominant Irritable Bowel Syndrome.

niversity of Western Sydney0 sites160 target enrollmentJuly 8, 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Constipation-predominant Irritable Bowel Syndrome
Sponsor
niversity of Western Sydney
Enrollment
160
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 8, 2009
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Western Sydney

Eligibility Criteria

Inclusion Criteria

  • 1\. Have a normal colonic evaluation test within the previous 5 years (colonoscopy or barium enema, or other colonic imaging).
  • 2\. Normal blood test results (full blood count, liver function test, urea \& creatinine) performed within the last 3 months.
  • 3\. Confirmed C\-IBS diagnosis by a Gastroenterologist or General Practitioner (GP).

Exclusion Criteria

  • 1\. Pregnancy or breast\-feeding.
  • 2\. Significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, or haematological disorders.
  • 3\. Diabetes mellitus requiring insulin therapy.
  • 4\. Epilepsy.
  • 5\. Inflammatory bowel disease.
  • 6\. Gastrointestinal tract neoplasm.
  • 7\. Celiac disease (by Tissue Transglutaminase (TTG) performed in the previous five years).
  • 8\. Current psychiatric illness or dementia (excluding clinically diagnosed depression or anxiety where the patient has been stable on medication for at least three months).
  • 9\. Current alcoholism or drug abuse.
  • 10\. Previous bowel surgery (excluding appendectomy, cholecystectomy, fundoplication).

Outcomes

Primary Outcomes

Not specified

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