Back to resultsStudying of Natural Constituents' Treatment of Plantar Warts
Primary Purpose
Plantar Wart
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Banaba Leaf Extract
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Wart
Eligibility Criteria
Inclusion Criteria:
- Male or female patient aged 18 years or more.
- Clinical evaluation
- Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm
Exclusion Criteria:
- Patient suspected to be immunocompromised
- Patient aged under 18 years
- Patient refusing to sign the consent
- Pregnant or lactating women
Sites / Locations
- Soad A. Mohamad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group (Group I)
Control group (Group II)
Arm Description
Outcomes
Primary Outcome Measures
Complete clinical remission of the warts
Number of warts (counts)
Clinical assessment of warts curement
Diameter of wart in cm
Secondary Outcome Measures
Pain asssesment
pain was assesed by VAS scoring (0) the least to (5) highest
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05592041
Brief Title
Studying of Natural Constituents' Treatment of Plantar Warts
Official Title
In-vitro and Randomized Controlled Clinical Studying of Natural Constituents' Anti-HPV Potential for Treatment of Plantar Warts Supported With in Silico Studies
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
December 18, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Deraya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Moringa banana nigella and Banna coat extract were prepared and formulated in the form of bi gel for transdermal delivery of these plant extracts. The formulation was prepared and charterized for organoleptic charters, morphology, and penetration efficacy. The optimised formulation was assessed clinically on patients suffering from plantar warts. The clinical study was phase 1 and interventional randomised allocation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Wart
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group (Group I)
Arm Type
Experimental
Arm Title
Control group (Group II)
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Banaba Leaf Extract
Other Intervention Name(s)
moringa banna nigella
Intervention Description
a herbal extract in the form of Bigel
Primary Outcome Measure Information:
Title
Complete clinical remission of the warts
Description
Number of warts (counts)
Time Frame
30 days
Title
Clinical assessment of warts curement
Description
Diameter of wart in cm
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Pain asssesment
Description
pain was assesed by VAS scoring (0) the least to (5) highest
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient aged 18 years or more.
Clinical evaluation
Number of warts lower than 10 on the 2 feet and total diameter of warts lower than 10 cm
Exclusion Criteria:
Patient suspected to be immunocompromised
Patient aged under 18 years
Patient refusing to sign the consent
Pregnant or lactating women
Facility Information:
Facility Name
Soad A. Mohamad
City
Minya
ZIP/Postal Code
05673
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Studying of Natural Constituents' Treatment of Plantar Warts
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