Study of Coriolus Versicolor Vaginal Gel for HPV Clearance and Cervical Lesion Improvement in Women Aged 30 to 50

What this Trial Is About

Researchers are evaluating whether a vaginal gel containing Coriolus versicolor extract can help clear high-risk Human Papillomavirus hrHPV and promote regression of Cervical Intraepithelial Neoplasia CIN grade 1 or 2 in women aged 30 to 50 years. This randomized controlled trial addresses the need for non-invasive treatments for women with mild to moderate cervical lesions who currently follow a watchful waiting approach. The study also aims to assess patient satisfaction, treatment compliance, and changes in the vaginal microbiome. Participants will be randomly assigned to one of two groups. The intervention group will apply the Coriolus versicolor-based vaginal gel daily for 21 days each month during the first three months, followed by application every other day for the next three months, with a 7-day break each month to accommodate menstruation. The control group will continue with the conventional watchful waiting strategy without active treatment. Both groups will be followed for six months. During the study, participants will undergo follow-up examinations including colposcopy, cervical biopsies, and self-collected vaginal swabs to monitor hrHPV status and vaginal microbiome changes. They will complete digital questionnaires assessing anxiety, stress, treatment compliance, and satisfaction. The primary outcome is hrHPV clearance after six months, with secondary outcomes including CIN regression and patient-reported measures. The total participation lasts six months with assessments at baseline and follow-up.

Effectiveness of a Vaginal Gel on CIN1/2 Regression and HPV Clearance.