Objective To evaluate the clinical efficacy and safety ofKushen Gel combined with oral fluconazole in the treatment of vulvovaginal candidiasis (VVC). Methods A multicenter, randomized, double-blind, placebo-controlled trial was conducted. Patients with VVC who visited four hospitals between June 2024 and October 2025 were recruited and randomly assigned in a 1∶1 ratio to the placebo group or the Kushen Gel group. Both groups received a single oral dose of fluconazole 150 mg. Additionally, the Kushen Gel group received intravaginal Kushen Gel, while the placebo group received a placebo gel with identical appearance and properties, both for 14 consecutive days. The primary efficacy endpoint was the clinical response rate at 7—10 days after drug discontinuation. Secondary efficacy endpoints included the proportion of patients with normalization of at least four vaginal microecological indicators, time to complete resolution of vulvar pruritus, pain, and abnormal discharge, vaginal cleanliness, and mycological recurrence rate at 25—31 days after drug discontinuation. Adverse events were monitored to evaluate safety. Results A total of 93 patients were randomized. At the 7—10 days post-treatment follow-up visit, the clinical response rate in the Kushen Gel group was significantly higher than that in the placebo group (87.50% vs 65.00%, P = 0.033 9). The proportion of patients achieving normalization of at least four vaginal microecological indicators was significantly higher in the Kushen Gel group compared with the placebo group [97.50% vs 77.50%, P = 0.0143]. The times to resolution of vulvar pruritus, pain, and abnormal discharge in the Kushen Gel group were all shorter than those in the placebo group, but the differences were not statistically significant (P > 0.05). At the 25—31 days post-treatment follow-up, the mycological recurrence rate was 10.53% (2/19) in the Kushen Gel group, which was lower than that in the placebo group (23.81%, 5/21). The incidence of adverse events was low in both groups, with no statistically significant difference between groups (P > 0.05), and no serious adverse events occurred. Conclusion The combination of Kushen Gel with oral fluconazole can alleviate clinical symptoms, enhance short-term clinical efficacy, and may help reduce the recurrence rate, as well as, the recovery of vaginal microecology in patients with VVC. The treatment is safe and possesses significant clinical value.

vulvovaginal candidiasis  /  Kushen Gel  /  vaginal microecology  /  randomized controlled trial  /  fluconazole