Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000744055
Ethics application status
Approved
Date submitted
1/09/2010
Date registered
7/09/2010
Date last updated
28/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Garlic and Candida: A Randomised Controlled Trial (PAThWAY Study)
Scientific title
A randomised controlled 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] 252460 0
Nil
Universal Trial Number (UTN)
U1111-1116-6012
Trial acronym
PAThWAY
(Potential Alternative Therapy: Women, Allicin, Yeast)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent vulvovaginal candidiasis 257976 0
Condition category
Condition code
Alternative and Complementary Medicine 258135 258135 0 0
Herbal remedies
Skin 258136 258136 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 garlic tablets (enteric coated tablets containing 350mg garlic powder) twice a day, with total daily dose of 2,100mg (6 tablets) per day for 2 weeks. The pilot study for this trial has already been registered (ACTRN12610000532000).
Intervention code [1] 257023 0
Treatment: Drugs
Intervention code [2] 257028 0
Prevention
Intervention code [3] 257157 0
Treatment: Other
Comparator / control treatment
3 lactose placebo tablets twice a day, with a total of 6 tablets per day
Control group
Placebo

Outcomes
Primary outcome [1] 258999 0
Vaginal colonisation with Candida in intervention and control groups assessed by daily vaginal swabs for 14 days during the luteal part of the menstrual cycle, for one cycle only, until menstruation.
Timepoint [1] 258999 0
Daily colony counts of Candida from day 14-28 of the menstrual cycle for one cycle only
Secondary outcome [1] 265225 0
Comparison of daily diary with daily quantitative colony counts of Candida to ascertain whether medications (e.g.antibiotics, vaginal creams etc) diet, sexual activity or other physical activity correlates with colony counts of Candida
Timepoint [1] 265225 0
Daily diary will be kept by each participant throughout the 2 weeks of the study, for approximately 14 days in the second half of the menstrual cycle until menstruation.

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
Allergy to garlic
Bleeding disorders / taking warfarin / peptic ulcers
Intended surgery during or immediately after the study period
Pregnant or breastfeeding

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation schedule will be devised by statistician at Dept of General Practice, University of Melbourne. This schedule will be given directly to pharmacist at Royal Women's Hospital, who allocates placebo/intervention according to schedule. 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)
Simple randomisation will be performed by using a randomisation table created by a computer software (i.e., computerised sequence generation).

Participants respond to advertisement. Eligibility will be determined via direct communication with participant. Eligible women sent plain language statement, consent form and entry questionnaire.
Simple randomisation will be performed by using a randomisation table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2010
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
14/07/2011
Date of last data collection
Anticipated
Actual
14/07/2011
Sample size
Target
60
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3141 0
3053

Funding & Sponsors
Funding source category [1] 257477 0
Charities/Societies/Foundations
Name [1] 257477 0
Shepherd Foundation
Country [1] 257477 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of General Practice
University of Melbourne
200 Berkeley St, Carlton 3053 VIC
Country
Australia
Secondary sponsor category [1] 256705 0
University
Name [1] 256705 0
Royal Melbourne Institute of Technology (RMIT)
Address [1] 256705 0
RMIT University Building 223
Level 1, Bundoora Campus Plenty Road
Bundoora, 3083 VIC
Country [1] 256705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259504 0
Royal Women's Hospital
Ethics committee address [1] 259504 0
Human Research Ethics Committee
Royal Women's Hospital
Cr Grattan St & Flemington Rd
Parkville VIC 3052
AUSTRALIA
Ethics committee country [1] 259504 0
Australia
Date submitted for ethics approval [1] 259504 0
Approval date [1] 259504 0
03/05/2010
Ethics approval number [1] 259504 0
09/55
Ethics committee name [2] 259505 0
University of Melbourne
Ethics committee address [2] 259505 0
Human Research Ethics Committee
Melbourne Research Office
The University of Melbourne
Victoria 3101
Ethics committee country [2] 259505 0
Australia
Date submitted for ethics approval [2] 259505 0
Approval date [2] 259505 0
28/08/2010
Ethics approval number [2] 259505 0
0932243.1

Summary
Brief summary
The initial pilot study for this trial was registered with ANZCTR (ACTRN12610000532000) and completed in July 2010. The purpose of this study is to ascertain whether oral garlic tablets reduce vaginal colonisation of Candida (the yeast that causes thrush) when taken in the second half of the menstrual cycle, in women of childbearing age. Women will be asked to take three garlic tablets (or placebo) for two weeks, as well as send daily vaginal swabs to the laboratory for analysis, and complete a daily diary. This will give information not yet known about colonisation patterns of Candida in the second half of the menstrual cycle, as well as whether or not oral garlic tablets may be helpful in reducing recurrences of episodes of vaginal thrush.
Trial website
Trial related presentations / publications
2013: Watson C, Grando D, Chondros P, Fairley CK, Myers S, Garland S, Pirotta M. The effect of oral garlic on vagina candida colony counts. A randomised placebo controlled double-blind trial. 1-9 British Journal of Obstetrics and Gynaecology.

2013: Watson C, Fairley CK, Grando D, Garland S, Myers S, Pirotta M. Associations of asymptomatic colonization of vaginal candida in women with a reported history of vulvovaginal candidiasis: an observational study. European Journal of Obstetrics and Reproductive Gynecology 169:376-379

2011 The effect of recurrent vulvovaginal candidiasis on women’s mental health status. ACNP conference, Brisbane
2012 Recruiting women for studies in sensitive subject matter. ASPOG 38th Scientific Meeting
2013 A Randomized Placebo Controlled Double Blind Trial of the Effects of Oral Garlic Supplements on Vaginal Candida Colony Counts. ISSVD World Congress, Mediterranean
2014 The Effect of Sexual Intercourse on Vaginal Colonisation with Candida. ASPOG Conference, Darwin Australia, 7th August 2014
2015 Workshop: Vulval Disorders. The 10th Conference of the Australian College of Nurse Practitioners, Melbourne
2015 Poster: The Effect of Sexual Intercourse on Vaginal Colonisation with Candida 2015 World STI & HIV Conference, Brisbane. 13-16th Sept
Public notes

Contacts
Principal investigator
Name 31529 0
Address 31529 0
Country 31529 0
Phone 31529 0
Fax 31529 0
Email 31529 0
Contact person for public queries
Name 14776 0
Cathy Watson
Address 14776 0
Department of General Practice
University of Melbourne
200 Berkeley St, Carlton 3052
Victoria
Country 14776 0
Australia
Phone 14776 0
+61 3 9035 5685
Fax 14776 0
+61 3 9347 6136
Email 14776 0
[email protected]
Contact person for scientific queries
Name 5704 0
Cathy Watson
Address 5704 0
Department of General Practice
University of Melbourne
200 Berkeley St, Carlton 3052
Victoria
Country 5704 0
Australia
Phone 5704 0
+61 3 9035 5685
Fax 5704 0
+61 3 9347 6136
Email 5704 0
[email protected]

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No Supporting Document Provided



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