Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000532000
Ethics application status
Approved
Date submitted
23/06/2010
Date registered
30/06/2010
Date last updated
28/06/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Garlic and Candida: A Pilot study (PAThWAY)
Scientific title
A randomised controlled pilot study comparing the effect of oral garlic tablets compared to oral placebo tablets on vaginal colonisation with Candida in women of childbearing age with a history of vulvovaginal candidiasis
Secondary ID [1] 252137 0
nil
Universal Trial Number (UTN)
U1111-1115-5431
Trial acronym
PAThWAY: Potential Alternative Therapy: Women, Allicin, Yeast
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vulvovaginal candidiasis 257609 0
Condition category
Condition code
Alternative and Complementary Medicine 257784 257784 0 0
Herbal remedies
Skin 257841 257841 0 0
Dermatological conditions
Infection 257842 257842 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two garlic tablets twice a day after food for 14 days
(garlic powder bulb 350mg X 2 for a daily total dose of 1400mg 4 tablets)
Intervention code [1] 256694 0
Treatment: Other
Intervention code [2] 256731 0
Prevention
Comparator / control treatment
Two lactose placebo tablets twice a day after food for 14 days
Control group
Placebo

Outcomes
Primary outcome [1] 258655 0
Vaginal colonisation with Candida in intervention and control groups using self collected vaginal swabs for the 14 days of the study
Timepoint [1] 258655 0
Daily colony counts of Candida from day 14-28 of the menstrual cycle for one menstrual cycle only
Secondary outcome [1] 264631 0
Colonisation patterns of Candida throughout the menstrual cycle
Timepoint [1] 264631 0
Daily colony counts over the luteal phase of one menstrual cycle for each participant

Eligibility
Key inclusion criteria
18-50 years, of reproductive age
Previous history of vulvovaginal candidiasis (VVC)
Asymptomatic for vaginitis (i.e. no abnormal vaginal discharge or itchiness)
Able to take two vaginal swabs and post them daily for approximately 14 days
Able and willing to take 2 herbal tablets twice a day for approximately 14 days
Agree not to self medicate with over the counter medications, herbal or complementary medicines, and abstain from added garlic in diet for the duration of the study
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Bleeding disorders / taking warfarin / peptic ulcers
Intended surgery during or immediately after the study period
Pregnant or breastfeeding

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 respond to advertisement. Determination whether they are eligible with direct communication with participant. Eligible women sent plain language statement, consent form and entry questionnaire. Once enrolled, given study number in order of enrolment.

Randomisation schedule devised by statistician at Dept of General Practice, University of Melbourne. This schedule given directly to pharmacist at Royal Women's Hospital, who allocates placebo/intervention according to schedule. No researchers are given the randomisation schedule and are unaware of the group in which the eligible participant is allocated. The containers are then sealed and given to researcher for distribution in order of enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation schedule is devised by statistician at Dept of General Practice, University of Melbourne using a simple randomisation table created by computer software (computorised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2010
Actual
2/06/2010
Date of last participant enrolment
Anticipated
Actual
2/07/2010
Date of last data collection
Anticipated
Actual
2/07/2010
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257191 0
Charities/Societies/Foundations
Name [1] 257191 0
Shepherd Foundation
Country [1] 257191 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of General Practice
200 Berkeley St
Carlton 3053 VICTORIA
Country
Australia
Secondary sponsor category [1] 256445 0
University
Name [1] 256445 0
Royal Melbourne Institute of Technology (RMIT)
Address [1] 256445 0
RMIT University Building 223, Level 1, Bundoora Campus Plenty Road, Bundoora, 3083 Victoria
Country [1] 256445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259221 0
Human Research Ethics Committee (HREC) University of Melbourne
Ethics committee address [1] 259221 0
Melbourne Research Office
University of Melbourne
Victoria 3010
Ethics committee country [1] 259221 0
Australia
Date submitted for ethics approval [1] 259221 0
17/02/2010
Approval date [1] 259221 0
13/05/2010
Ethics approval number [1] 259221 0
0933026

Summary
Brief summary
This study is a pilot study to take place prior to a larger Randomised Controlled Trial (RCT) "Garlic and Candida: An Exploratory Study." The RCT proposes to investigate the biological plausibility of oral garlic reducing recurrences of vaginal thrush by reducing the vaginal colonisation of Candida albicans.

The RCT will involve women taking either oral daily garlic tablets or placebo, keeping a daily diary, and self collecting daily vaginal swabs and posting them to the laboratory during the second half of their menstrual cycle. This pilot study will evaluate the methodology by assessing the tolerability of the garlic tablets, the postage of the swabs, and the daily diary. It will also include a validation study on postage of vaginal swabs.
Trial website
none
Trial related presentations / publications
2012: Watson C, Grando D, Garland SM, Myers S, Fairley CK, Pirotta M. Brief Report: premenstrual vaginal colonization of candida and symptoms of vaginitis. Journal of Medical Microbiology 61:1580-1583
Public notes

Contacts
Principal investigator
Name 31313 0
Address 31313 0
Country 31313 0
Phone 31313 0
Fax 31313 0
Email 31313 0
Contact person for public queries
Name 14560 0
Cathy Watson
Address 14560 0
Department of General Practice
University of Melbourne
200 Berkeley St
Carlton 3103
Victoria
Country 14560 0
Australia
Phone 14560 0
+61 3 9035 5685
Fax 14560 0
+61 3 9347 6136
Email 14560 0
[email protected]
Contact person for scientific queries
Name 5488 0
Cathy Watson
Address 5488 0
Department of General Practice
University of Melbourne
200 Berkeley St
Carlton 3103
Victoria
Country 5488 0
Australia
Phone 5488 0
+61 3 9035 5685
Fax 5488 0
+61 3 9347 6136
Email 5488 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
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