Exploratory randomized open-label clinical trial of

Background: Vaginal candidiasis is the second most common cause of vaginal infection worldwide, affecting nearly 70-75% of women at least once during their lifetime, with recurrence in approximately 45%. In Ayurveda, its clinical presentation resembles Objective: To generate preliminary clinical and microbiological outcome estimates and evaluate the safety of adding Methods: A single-center, open-label, randomized exploratory clinical trial (CTRI/2024/08/072177) enrolled 36 of 42 screened participants and randomized (1:1 allocation) into two groups (18 per group). 32 participants (16 per group) completed study and were analyzed. Group A received Results: Both groups showed improvement in clinical symptoms and microbiological parameters. Exploratory analyses suggested earlier improvements in vaginal discharge, pruritus and Candida spore count in the combination group. Exploratory analyses suggested between-group differences from Day 5 onwards; however, these observations should be interpreted as hypothesis-generating rather than confirmatory evidence. Conclusion: The addition of Clinical trial registration: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTEwODU2&Enc=&userName=, identifier: CTRI/2024/08/072177.