Garlic and Candida: A Pilot study (PAThWAY)

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000532000

Acronym

PAThWAY: Potential Alternative Therapy: Women, Allicin, Yeast

Enrollment

Registered

2010-06-30

Start date

2010-06-02

Completion date

2010-07-02

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 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.

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Exclusion criteria

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

Outcome results