Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000558224
Ethics application status
Approved
Date submitted
7/07/2009
Date registered
8/07/2009
Date last updated
9/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical and physiological evaluation of a Chinese herbal medicine for constipation-predominant Irritable Bowel Syndrome (C-IBS Trial).
Scientific title
A double blind randomised placebo controlled clinical trial testing the effectiveness of a Chinese herbal medicine extract formulation for constipation-predominant Irritable Bowel Syndrome.
Secondary ID [1] 281364 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
C-IBS Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation-predominant Irritable Bowel Syndrome 237079 0
Condition category
Condition code
Alternative and Complementary Medicine 237401 237401 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 236799 0
Treatment: Drugs
Comparator / control treatment
A placebo has been designed to match the active formulation in size, weight, colour, taste and smell. The placebo is in powder form consisting of Corn Starch, Caramel, Citric Acid, Lemon Yellow Powder (H1794), Brown Powder (H9885), Sucrose Octa acetate. Dosage is 5 oral capsules twice per day, morning and evening 20 minutes before food for 8 weeks duration.
Control group
Placebo

Outcomes
Primary outcome [1] 238204 0
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.
Timepoint [1] 238204 0
Baseline, 2 weeks, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [1] 244507 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the Irritable Bowel Syndrome (IBS) Symptom Severity Scale
Timepoint [1] 244507 0
Baseline, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [2] 244508 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the Work Productivity and Activity Impairment Questionnaire for Constipation-predominant Irritable Bowel Syndrome (C-IBS) (WPAI:IBS-C)
Timepoint [2] 244508 0
Baseline, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [3] 244509 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the Bristol Stool Form Scale.
Timepoint [3] 244509 0
Baseline, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [4] 244510 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the Irritable Bowel Syndrome (IBS) Quality of Life Measure (IBSQOL).
Timepoint [4] 244510 0
Baseline, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [5] 244511 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using Dietary changes which includes coffee, alcoholic and fibre consumption.
Timepoint [5] 244511 0
Baseline, 2 weeks, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [6] 244512 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the Short-Form Health Survey (SF36, version 2) Health-related quality of life measurement.
Timepoint [6] 244512 0
Baseline, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [7] 244513 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the NEO- Five Factor Inventory (NEO-FFI).
Timepoint [7] 244513 0
Baseline
Secondary outcome [8] 244514 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using the Depression Anxiety Stress Scale (DASS).
Timepoint [8] 244514 0
Baseline, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [9] 244516 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using Symptom Comparison.
Timepoint [9] 244516 0
4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [10] 244517 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status using Other Health Care Utilisation visits.
Timepoint [10] 244517 0
Baseline, 4 weeks, 8 weeks and 16 weeks after commencing the trial intervention.
Secondary outcome [11] 244518 0
Chinese herbal medicine benefits on the digestive tract and psychosocial status for the Physiological Assessment uses a Visual Analog Scale (VAS) to record bowel sensations of urgency, gas, pain/discomfort.
Timepoint [11] 244518 0
Baseline and 8 weeks after commencing the trial intervention.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants must have a completed referral form from their GP or gastroenterologist prior to their first screening appointment in the trial. This referral confirms a diagnosis of constipation predominant Irritable Bowel Syndrome (C-IBS) as per the Rome III criteria and if the participant is suitable for screening. If the participant meets the eligibility criteria at screening they will be allocated a coded trial number according to the trial site. Each site is allocated a block of participant numbers which are consecutively allocated. Trial medication has been previously numbered to match the site allocation and enrolled subjects are provided with their trial medication and (coded) number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer randomisation block sequence was generated at a central administrative site by a third party not involved in the trial and the trial intervention was also labelled in number (coded) containers to maintain concealment for researches. Randomisation is conducted in blocks of four, so every four consecutive numbers has two random active and placebo sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1864 0
2214
Recruitment postcode(s) [2] 1865 0
2560
Recruitment postcode(s) [3] 1866 0
2116
Recruitment postcode(s) [4] 1867 0
2065
Recruitment postcode(s) [5] 1868 0
2025
Recruitment postcode(s) [6] 1869 0
2000
Recruitment postcode(s) [7] 1870 0
2088
Recruitment postcode(s) [8] 1871 0
2021
Recruitment postcode(s) [9] 1872 0
2210
Recruitment postcode(s) [10] 1873 0
2747

Funding & Sponsors
Funding source category [1] 237249 0
Government body
Name [1] 237249 0
National Health and Medical Research Council (NHMRC)
Country [1] 237249 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked bag 1797
Penrith South DC
NSW 1797
Country
Australia
Secondary sponsor category [1] 236735 0
None
Name [1] 236735 0
Address [1] 236735 0
Country [1] 236735 0
Other collaborator category [1] 741 0
Hospital
Name [1] 741 0
Gastrointestinal Investigation Unit, Royal North Shore Hospital
Address [1] 741 0
University of Sydney
Department of Gastroenterology
Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Country [1] 741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239352 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 239352 0
Ethics committee country [1] 239352 0
Australia
Date submitted for ethics approval [1] 239352 0
Approval date [1] 239352 0
24/11/2008
Ethics approval number [1] 239352 0
H6374
Ethics committee name [2] 239353 0
Northern Sydney Central Coast Health (NSCCH) Human Research Ethics Committee
Ethics committee address [2] 239353 0
Ethics committee country [2] 239353 0
Australia
Date submitted for ethics approval [2] 239353 0
Approval date [2] 239353 0
13/11/2008
Ethics approval number [2] 239353 0
0810-214M

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29786 0
Address 29786 0
Country 29786 0
Phone 29786 0
Fax 29786 0
Email 29786 0
Contact person for public queries
Name 13033 0
Suzannah Bourchier
Address 13033 0
CompleMED
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 13033 0
Australia
Phone 13033 0
+61 2 4620 3283
Fax 13033 0
+61 2 4620 3291
Email 13033 0
[email protected]
Contact person for scientific queries
Name 3961 0
Professor Alan Bensoussan
Address 3961 0
University of Western Sydney
Locked Bag 1797
Penrith South DC
NSW 1797
Country 3961 0
Australia
Phone 3961 0
+61 2 4620 3709
Fax 3961 0
Email 3961 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.