Anogenital Wart Clinical Trial
Official title:
The Efficacy of Ethanol Extract of Red Betel Leaves (Piper Crocatum) as Topical Patient-Applied Therapy In Anogenital Warts The Study of Foxp3+ Treg, Tumor Growth Factor (TGF)-β1, and Interferon (IFN)-γ Expression
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%
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 1. Extraction of Piper crocatum with ethanol assisted in a microwave-assisted extraction (MAE) 2. The dissolution and active substances are separated by evaporation using a rotary evaporator to obtain the extract in the form of a thick solution 3. freeze-drying is performed to obtain a stable thick extract 4. 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: 1. Type 1 error 5% 2. Power of Study 80% 3. Assuming the effect size of cohen d (in reducing the size of warts) is 0.5 4. equal allocation between two arms total sample: 100 participants Proposed analysis: Intention to treat (ITT) with sensitivity and subgroup analysis ;