ANZCTR - Registration

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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]

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

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Skin

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]

Treatment: Drugs

Intervention code [2]

Prevention

Intervention code [3]

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]

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]

Daily colony counts of Candida from day 14-28 of the menstrual cycle for one cycle only

Secondary outcome [1]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

3053

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Shepherd Foundation

Address [1]

Shepherd Foundation
Suite 33, Cabrini Medical Centre
MALVERN VIC 3144

Country [1]

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]

University

Name [1]

Royal Melbourne Institute of Technology (RMIT)

Address [1]

RMIT University Building 223
Level 1, Bundoora Campus Plenty Road
Bundoora, 3083 VIC

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Women's Hospital

Ethics committee address [1]

Human Research Ethics Committee
Royal Women's Hospital
Cr Grattan St & Flemington Rd
Parkville VIC 3052
AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/05/2010

Ethics approval number [1]

09/55

Ethics committee name [2]

University of Melbourne

Ethics committee address [2]

Human Research Ethics Committee
Melbourne Research Office
The University of Melbourne
Victoria 3101

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

28/08/2010

Ethics approval number [2]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Cathy Watson

Address

Department of General Practice
University of Melbourne
200 Berkeley St, Carlton 3052
Victoria

Country

Australia

Phone

+61 3 9035 5685

Fax

+61 3 9347 6136

cathyw@unimelb.edu.au

Contact person for scientific queries

Name

Cathy Watson

Address

Department of General Practice
University of Melbourne
200 Berkeley St, Carlton 3052
Victoria

Country

Australia

Phone

+61 3 9035 5685

Fax

+61 3 9347 6136

cathyw@unimelb.edu.au

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

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Documents added automatically

No additional documents have been identified.

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