Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
NCT ID:
NCT05622916
Brief Summary:
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%
Detailed Description:
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
Study:
NCT05622916
Study Brief:
Protocol Section:
NCT05622916