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CompletedPhase 2Phase 3ACTRN12609000558224

Clinical and physiological evaluation of a Chinese herbal medicine for constipation-predominant Irritable Bowel Syndrome (C-IBS Trial).

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

Sponsor

University of Western Sydney

Enrollment

160 participants

Start Date

Jun 22, 2009

Study Type

Interventional

Conditions

Constipation-predominant Irritable Bowel Syndrome

Summary

This research project will test whether Chinese herbal medicine is useful for treating constipation predominant Irritable Bowel Syndrome (C-IBS). C-IBS has multiple symptoms, including abdominal pain, bloating, constipation and changed bowel habits. The Chinese herbal formulation being tested has been designed to address the multiple symptoms of C-IBS.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria3

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

Exclusion Criteria13

  • Pregnancy or breast-feeding.
  • Significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, or haematological disorders.
  • Diabetes mellitus requiring insulin therapy.
  • Epilepsy.
  • Inflammatory bowel disease.
  • Gastrointestinal tract neoplasm.
  • Celiac disease (by Tissue Transglutaminase (TTG) performed in the previous five years).
  • Current psychiatric illness or dementia (excluding clinically diagnosed depression or anxiety where the patient has been stable on medication for at least three months).
  • Current alcoholism or drug abuse.
  • Previous bowel surgery (excluding appendectomy, cholecystectomy, fundoplication).
  • Any serious medical or psychological disorder likely to preclude completion of the trial.
  • The use of Quinine, Digoxin, Thiazides, Potassium Sparing Diuretics, Ephedrine Hydrochloride, Iron-containing agents and Pancreatin drugs.
  • Severe Idiopathic constipation.

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Interventions

A seven ingredient plant based Chinese herbal medicine formulation extracted into powder form. Dosage is 5 oral capsules twice per day, morning and evening 20 minutes before food for 8 weeks duration.

A seven ingredient plant based Chinese herbal medicine formulation extracted into powder form. Dosage is 5 oral capsules twice per day, morning and evening 20 minutes before food for 8 weeks duration.

Locations(1)

Australia

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ACTRN12609000558224