A Comparative randomized controlled trial evaluating the efficacy and safety of intravaginal boric acid versus oral fluconazole in the management of recurrent vulvovaginal candidiasis (RVVC)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in Composite clinical scoring
研究概览
简要总结
This study aims to compare the efficacy of intravaginal boric acid and oral fluconazole in
the management of recurrent vulvovaginal candidiasis (RVVC), focusing on clinical
outcomes, quality of life, and baseline Dectin-1 status. R VVC, characterized by four or
more symptomatic episodes of vulvovaginal candidiasis within a year, has become
increasingly difficult to treat due to rising resistance to azole antifungals, especially among
non-albicans Candida species. Although boric acid has demonstrated promising results in
azole-resistant infections, head-to-head comparative studies with fluconazole incorporating
objective and standardized outcome measures remain limited. In this randomized study,
women aged 18 to 50 years with clinically confirmed RVVC will be enrolled after
informed consent. Eligible participants will be randomized in a I: 1 ratio to receive either
intravaginal boric acid (600 mg once daily for 14 days) or oral fluconazole (150 mg on
days 0, 3, 6, and 14). A composite clinical symptom score will be used to quantify
symptom severity, while the Vulvar Disease Quality of Life Index (VDQLI) will assess
patient-reported impact on daily life. Additionally, Dectin-1 levels will be measured at
baseline from vaginal secretions using ELISA, to explore innate immune function related to
fungal recognition. Women who are pregnant, lactating, immunocompromised, or have
taken antifungal medication in the past two weeks will be excluded from the study. The
primary outcome is improvement in the composite symptom score post-treatment, and
secondary outcomes include enhancement in quality of life and the descriptive analysis of
baseline Dectin-1 levels. While boric acid is expected to demonstrate equal or superior
clinical and QoL outcomes, baseline Dectin-1 profiling may help uncover immunological
predispositions contributing to RVVC susceptibility. The results may contribute to refining
individualized treatment strategies and understanding host-pathogen interactions in
recurrent fungal infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients aged 18-50 years.
- •History of~3 episodes of vulvovaginal candidiasis in the past 12 months.
- •Current symptomatic episode with microbiological confirmation of Candida spp.
- •By gram stain or KOH from vaginal smear
- •Willing to provide informed consent and comply with study procedures.
- •Agree to use barrier contraception during the study period.
排除标准
- •Known hypersensitivity to boric acid or fluconazole.
- •Use of systemic or topical antifungal therapy within the past 2 weeks.
- •Use of intravaginal probiotics or antibiotics in the last 1 week.
- •Pregnant or lactating women.
- •Current use of immunosuppressive drugs or corticosteroids.
- •Concomitant sexually transmitted infections (e.g., trichomoniasis, chlamydia, gonorrhea) based on history or laboratory findings.
- •Women with abnormal menstrual bleeding, active pelvic inflammatory disease, or other vulvovaginal disorders that may confound the assessment.
- •Sexually inactive females ( due to anticipated difficulty of intra vaginal capsule administration).
结局指标
主要结局
Improvement in Composite clinical scoring
时间窗: At Baseline | At 2 weeks, | At 4 weeks, 8 weeks & 12 weeks (If Relapse is present)
次要结局
- 1. Recurrence rate during post-treatment follow up period(2. Adverse effects in each group (monitored at follow-up visits).)
研究者
Dr Tushar Pawar
AIIMS Jodhpur