Garlic and Candida: A Randomised Controlled Trial (PAThWAY Study)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000744055

Acronym

PAThWAY (Potential Alternative Therapy: Women, Allicin, Yeast)

Enrollment

Registered

2010-09-07

Start date

2010-10-01

Completion date

2011-07-14

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

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.

Interventions

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).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

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

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

Outcome results