Exploratory randomized open-label clinical trial of Triphalā Kaṣāya vaginal douche (Yoni prakṣālana) with and without Gomūtra Arka in vaginal candidiasis.

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 Ślaiṣmikī Yonivyāpad. Preliminary clinical evidence suggests Yoni Prakṣālana (vaginal douche) with Triphalā Kaṣāya improves the clinical symptoms within the first 7 days of therapy. Classical Ayurvedic texts recommended combining Triphalā Kaṣāya and Gomūtra for srava-pradhāna Ślaiṣmikī Yonivyāpat, but, to date, no randomized controlled studies have explored the potential additive effect of Gomūtra Arka with Triphalā Kaṣāya using microbiological outcome assessment.

OBJECTIVE: To generate preliminary clinical and microbiological outcome estimates and evaluate the safety of adding Gomūtra Arka to Triphalā Kaṣāya Yoni Prakṣālana in women with vaginal candidiasis, thereby informing the design of future confirmatory randomized controlled trials.

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 Triphalā Kaṣāya Yoni Prakṣālana alone, and Group B received Triphalā Kaṣāya combined with Gomūtra Arka for 7 consecutive days. Outcomes were assessed on Day 0, 3, 5, and 8. The exploratory primary outcome was change in candida spore count quantified using ImageJ software. Exploratory secondary outcome was changes in vaginal discharge and pruritus, assessed using discharge grading scale and the 5-D Pruritus Scale. Safety was prospectively monitored throughout the intervention by adverse event surveillance.

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 Gomūtra Arka to Triphalā Kaṣāya Yoni Prakṣālana was feasible and associated with favorable exploratory clinical and microbiological outcomes. These preliminary findings support adequately powered multicentre randomized controlled trials to confirm therapeutic effectiveness and further evaluate safety and mechanisms of action.

CLINICAL TRIAL REGISTRATION: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTEwODU2&Enc=&userName=, identifier: CTRI/2024/08/072177.