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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000558224

Acronym

C-IBS Trial

Enrollment

160

Registered

2009-07-08

Start date

2009-06-22

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Outcome results