Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05622916
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-11-21
First Post:
2022-11-14
Brief Title:
Topical Ethanol Extract Piper Crocatum for Anogenital Warts
Sponsor:
Hasanuddin University
Organization:
Hasanuddin University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TGFTumor Growth Factor -β1 and IFNinterferon -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
the clinical efficacy of treating anogenital warts
the expression of Foxp3 regulatory T Treg TGFTumor Growth Factor -β1 and IFNinterferon -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 A630
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 05
4 equal allocation between two arms total sample 100 participants
Proposed analysis
Intention to treat ITT with sensitivity and subgroup analysis
A randomized controlled trial
Population
Diagnosed with Condyloma Acuminata International Classification of Disease 10 code A630
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 05
4 equal allocation between two arms total sample 100 participants
Proposed analysis
Intention to treat ITT with sensitivity and subgroup analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None