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

Phase 2

Completed

• Conditions: Constipation-predominant Irritable Bowel Syndrome; Alternative and Complementary Medicine - Herbal remedies

• Registration Number: ACTRN12609000558224
• Lead Sponsor: niversity of Western Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

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).

11. Any serious medical or psychological disorder likely to preclude completion of the trial.

12. The use of Quinine, Digoxin, Thiazides, Potassium Sparing Diuretics, Ephedrine Hydrochloride, Iron-containing agents and Pancreatin drugs.

13. Severe Idiopathic constipation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global Improvement in Irritable Bowel Syndrome Adequate Relief of symptoms is used to determine if a standardised Chinese herbal medicine preparation is effective and well tolerated for up to 8 weeks of treatment.[Baseline, 2 weeks, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.]