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CTRI Number  CTRI/2026/02/104172 [Registered on: 18/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Boric Acid (Vaginal) Compared With Fluconazole (Oral) for Repeat Vaginal Candida Infections 
Scientific Title of Study   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) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tushar Pawar 
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan)

Jodhpur
RAJASTHAN
342005
India 
Phone  09561857844  
Fax    
Email  tusharpawar7456@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Patra 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan)

Jodhpur
RAJASTHAN
342005
India 
Phone  9650450413  
Fax    
Email  patrohere@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman Patra 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan)

Jodhpur
RAJASTHAN
342005
India 
Phone  9650450413  
Fax    
Email  patrohere@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  AIIMS Jodhpur 
Address  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tushar Pawar  Department of Dermatology, Venereology and Leprosy, AIIMS Jodhpur.  All India Institute of Medical Sciences, Jodhpur Basni Industrial Area Phase 2, Jodhpur - 342005 (Rajasthan)
Jodhpur
RAJASTHAN 		 09561857844

tusharpawar7456@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences Basni Jodhpur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B373||Candidiasis of vulva and vagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 at bedtime for 14 days. 
Comparator Agent  Oral Fluconazole (Group B) in cases of Recurrent vulvovaginal candidiasis  Group B (Fluconazole Group): Route : Oral Dose : Fluconazole 150 mg every 72 hours for 3 doses (Day 0, 3, 6, 14) Total duration : 14 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  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) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in Composite clinical scoring  At Baseline
At 2 weeks,
At 4 weeks, 8 weeks & 12 weeks (If Relapse is present) 
 
Secondary Outcome  
Outcome  TimePoints 
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 RVVC 		 Recurrence rate, Adverse event: At every follow up visit
Mycology cure : Based on Baseline simple & if relapse/Treatment failure present at 2 weeks  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   02/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
 
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