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

Phase 2

Recruiting

• Conditions: recurrent vulvovaginal candidiasis; Alternative and Complementary Medicine - Herbal remedies; Infection - Other infectious diseases; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12624000204549
• Lead Sponsor: Integria Healthcare (Australia) Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Females with medically diagnosed recurrent vulvovaginal candidiasis (RVVC); and gastrointestinal symptoms of candida overgrowth for a minimum of four weeks
- No serious current illnesses or specific chronic illness (per exclusion criteria)
- Participants must be on contraception, and those participants who choose to use hormonal contraception should be on stable levels at least 6 weeks prior to and during the trial
- Any prescription medication use by participants (other than that listed in exclusion criteria) must be stable for six weeks or more prior to trial
- Ability and willingness to collect vaginal swabs; - Females with medically diagnosed recurrent vulvovaginal candidiasis (RVVC); and gastrointestinal symptoms of candida overgrowth for a minimum of four weeks
- No serious current illnesses or specific chronic illness (per exclusion criteria)
- Participants must be on contraception, and those participants who choose to use hormonal contraception should be on stable levels at least 6 weeks prior to and during the trial
- Any prescription medication use by participants (other than that listed in exclusion criteria) must be stable for six weeks or more prior to trial
- Ability and willingness to collect vaginal swabs

Exclusion Criteria

- Pregnant, planning pregnancy or breastfeeding
- Not willing to use contraception for the duration of the study
- Taking warfarin or any other anti-coagulant medication, diabetic medication, corticosteroids, antibiotics, or immunosuppressive medications/treatments
- Diagnosed with cancer (if active within last five years and excepting skin cancer)
- Individuals diagnosed with significant chronic illness including inflammatory bowel disease, liver disorders, kidney disease, autoimmune disorders, pelvic inflammatory disease, cystitis, sexually transmitted infections (STI), or any other medically diagnosed vulvovaginal conditions (excepting RVVC)
- Treatment of any vaginal infection, STI or urinary tract infection within the last six weeks including the use of vaginal douches, pessaries, probiotics (including vaginal and oral administration) for any reason
- Use of corticosteroids or oral antibiotics for any condition within the last four weeks
- Use of any antifungal treatments regularly for control of RVVC, including medications (i.e., Nystatin or fluconazole) or herbal treatment (i.e., Pau D’arco or horopito). Probiotics are permissible providing the use is regular for four weeks or more and ongoing
- Currently unwell with acute infection or fever or having Covid-19 within the last four weeks
- In poor general health as assessed by Study Investigators; - Pregnant, planning pregnancy or breastfeeding
- Not willing to use contraception for the duration of the study
- Taking warfarin or any other anti-coagulant medication, diabetic medication, corticosteroids, antibiotics, or immunosuppressive medications/treatments
- Diagnosed with cancer (if active within last five years and excepting skin cancer)
- Individuals diagnosed with significant chronic illness including inflammatory bowel disease, liver disorders, kidney disease, autoimmune disorders, pelvic inflammatory disease, cystitis, sexually transmitted infections (STI), or any other medically diagnosed vulvovaginal conditions (excepting RVVC)
- Treatment of any vaginal infection, STI or urinary tract infection within the last six weeks including the use of vaginal douches, pessaries, probiotics (including vaginal and oral administration) for any reason
- Use of corticosteroids or oral antibiotics for any condition within the last four weeks
- Use of any antifungal treatments regularly for control of RVVC, including medications (i.e., Nystatin or fluconazole) or herbal treatment (i.e., Pau D’arco or horopito). Probiotics are permissible providing the use is regular for four weeks or more and ongoing
- Currently unwell with acute infection or fever or having Covid-19 within the last four weeks
- In poor general health as assessed by Study Investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety [Comparison of blood biochemistry parameters (including electrolytes, liver function, kidney function and red/white cell parameters). baseline, 12 weeks and 24 weeks post-treatment commencement];Safety [Comparison of blood biochemistry parameters (including electrolytes, liver function, kidney function and red/white cell parameters). baseline, 12 weeks and 24 weeks post-treatment commencement]