Boric Acid (Vaginal) Compared With Fluconazole (Oral) for Repeat Vaginal Candida Infections

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) - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/02/104172

Enrollment

Registered

2026-02-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B373- Candidiasis of vulva and vagina

Interventions

Intervention1: Intravaginal boric acid capsules (Group A) in case of Recurrent vulvovaginal candidiasis: Group A (Boric Acid Group): Route :Intravaginal Dose :Boric acid capsules (600 mg) once daily

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-50 years. 2. History of~3 episodes of vulvovaginal candidiasis in the past 12 months. 3. Current symptomatic episode with microbiological confirmation of Candida spp. By gram stain or KOH from vaginal smear 4. Willing to provide informed consent and comply with study procedures. 5. Agree to use barrier contraception during the study period.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity to boric acid or fluconazole. 2. Use of systemic or topical antifungal therapy within the past 2 weeks. 3. Use of intravaginal probiotics or antibiotics in the last 1 week. 4. Pregnant or lactating women. 5. Current use of immunosuppressive drugs or corticosteroids. 6. Concomitant sexually transmitted infections (e.g., trichomoniasis, chlamydia, gonorrhea) based on history or laboratory findings. 7. Women with abnormal menstrual bleeding, active pelvic inflammatory disease, or other vulvovaginal disorders that may confound the assessment. 8. Sexually inactive females ( due to anticipated difficulty of intra vaginal capsule administration)

Design outcomes

Primary

Measure	Time frame
Improvement in Composite clinical scoringTimepoint: At Baseline At 2 weeks, At 4 weeks, 8 weeks & 12 weeks (If Relapse is present)	—

Secondary

Measure	Time frame
1. Recurrence rate during post-treatment follow up period 2. Adverse effects in each group (monitored at follow-up visits). 3. Mycological cure: Negative microscopy and/or culture at 2 weeks. 4. Candida species identification & antifungal sensitivity 5. Evaluate the relationship between vaginal dectin-1 levels & the risk of recurrence in VVC 6. Identifying the associated factors contributing to RVVCTimepoint: Recurrence rate, Adverse event: At every follow up visit Mycology cure : Based on Baseline simple & if relapse/Treatment failure present at 2 weeks	—

Measure

Time frame

1. Recurrence rate during post-treatment follow up period 2. Adverse effects in each group (monitored at follow-up visits). 3. Mycological cure: Negative microscopy and/or culture at 2 weeks. 4. Candida species identification & antifungal sensitivity 5. Evaluate the relationship between vaginal dectin-1 levels & the risk of recurrence in VVC 6. Identifying the associated factors contributing to RVVCTimepoint: Recurrence rate, Adverse event: At every follow up visit Mycology cure : Based on Baseline simple & if relapse/Treatment failure present at 2 weeks

—

Countries

India

Contacts

Public ContactDr Suman Patra

AIIMS Jodhpur

patrohere@gmail.com9650450413

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026