Garlic and Candida: A Randomised Controlled Trial (PAThWAY Study)
Phase 1
Completed
- Conditions
- Recurrent vulvovaginal candidiasisAlternative and Complementary Medicine - Herbal remediesSkin - Dermatological conditions
- Registration Number
- ACTRN12610000744055
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Daily colony counts of Candida from day 14-28 of the menstrual cycle for one cycle only]
- Secondary Outcome Measures
Name Time Method 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[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.]