Studying of Natural Constituents' Treatment of Plantar Warts

May 15, 2024 updated by: Soad Ali, Deraya University

In-vitro and Randomized Controlled Clinical Studying of Natural Constituents' Anti-HPV Potential for Treatment of Plantar Warts Supported With in Silico Studies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 05673
        • Soad A. Mohamad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group (Group I)
Drug: Banaba Leaf Extract
a herbal extract in the form of Bigel
Other Names:
  • moringa banna nigella
No Intervention: Control group (Group II)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete clinical remission of the warts
Time Frame: 30 days
Number of warts (counts)
30 days
Clinical assessment of warts curement
Time Frame: 30 days
Diameter of wart in cm
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain asssesment
Time Frame: 30 days
pain was assesed by VAS scoring (0) the least to (5) highest
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2022

Primary Completion (Actual)

December 18, 2022

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-HPV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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