Study Design :~A randomized controlled trial~Population:~Diagnosed with Condyloma Acuminata (International Classification of Disease 10 code A.63.0)~Intervention period :~8 weeks of daily topical intervention with follow-up at week 12~Detailed formulation~Extraction of Piper crocatum with ethanol assisted in a microwave-assisted extraction (MAE)~The dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution~freeze-drying is performed to obtain a stable thick extract~preparation of ointment by adding formulation of ethanol extract of red betel leaves with 50 mg of white vaseline to achieve 30% concentration~Settings:~Outpatient care at the designated hospital~Participants:~Consecutive recruitment~Sample Size Estimation:~Following the formula of two different means, with the indicator, as follows:~Type 1 error 5%~Power of Study 80%~Assuming the effect size of cohen d (in reducing the size of warts) is 0.5~equal allocation between two arms total sample: 100 participants~Proposed analysis:~Intention to treat (ITT) with sensitivity and subgroup analysis
This clinical trial aims to assess the efficacy of topical Piper crocatum in treating Anogenital warts. It aims to answer~the clinical efficacy of treating anogenital warts~the expression of Foxp3+ regulatory T (Treg), TGF/Tumor Growth Factor -β1, and IFN/interferon -γ of anogenital wart lesion Participants will be allocated into two topical treatments, intervention and active comparator Trichloroacetic Acid (TCA) 90%. The researchers assume that intervention is superior compared to TCA 90%