RecruitingPhase 2ACTRN12624000204549

Oral safety and efficacy of eucalypt sap resin in the management of recurrent vulvovaginal candidiasis

Pilot oral safety and efficacy of eucalypt sap resin for the management of recurrent vulvovaginal candidiasis (RVVC) and associated gastrointestinal symptoms: A comparative, 2-arm, double-blinded randomised study


Sponsor

Integria Healthcare (Australia) Pty Ltd.

Enrollment

24 participants

Start Date

May 15, 2024

Study Type

Interventional

Conditions

Summary

The purpose of this study is to assess safety of internal eucalypt sap resin consumption and also to explore if a low dose taken over a period of six months may be able to decrease vulvo-vaginal candidiasis episodes and concurrent gastrointestinal symptoms in women with recurrent vulvo-vaginal candidiasis (RVVC) and gastrointestinal symptoms of microbial imbalance. With the prevalence of RVVC and lack of safe long-term treatments for managing the symptoms of candida overgrowth (both gastrointestinal and vaginal), we are investigating this ingredient for potential in the management of RVVC alongside long-term safety.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

Recurrent vulvovaginal candidiasis (RVVC) — commonly known as recurrent thrush — affects many women and can cause persistent discomfort, itching, and disruption to daily life. Existing antifungal treatments are effective short-term but are not ideal for long-term use, and many women also notice gut symptoms they associate with candida overgrowth. This study explores whether eucalypt sap resin, a natural plant-derived ingredient, might offer a safe alternative. Participants will take a low dose of eucalypt sap resin daily for six months, with vaginal swabs and questionnaires used to track whether thrush episodes decrease and gut symptoms improve. The study also carefully monitors safety to ensure the ingredient is well-tolerated when consumed internally over an extended period. You may be eligible if you are a woman aged 18 to 65 with medically diagnosed recurrent thrush and gastrointestinal symptoms, who is using contraception and not pregnant. People taking anticoagulants, immunosuppressants, antifungals, antibiotics, or corticosteroids, or those with serious chronic conditions such as inflammatory bowel disease, autoimmune disorders, or active cancer are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants will be directed to take one capsule orally per day in the morning, with food for 24 weeks. Arm A capsules - contain 700 mg of powdered Eucalypt sap resin Compliance will be monitored

Participants will be directed to take one capsule orally per day in the morning, with food for 24 weeks. Arm A capsules - contain 700 mg of powdered Eucalypt sap resin Compliance will be monitored by return capsule count A subset of women in each group (maximum n=12) will be offered vaginal microbiome testing. This is exploratory testing and will be offered at the researchers discretion.


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12624000204549