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Studying of Natural Constituents' Treatment of Plantar Warts

Sponsor
Deraya University (Other)
Overall Status
Completed
CT.gov ID
NCT05592041
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.7
Actual Duration (Months)
7.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Banaba Leaf Extract
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 20, 2022
Actual Primary Completion Date :
Dec 18, 2022
Actual Study Completion Date :
Jan 10, 2023

Arms and Interventions

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)

    Outcome Measures

    Primary Outcome Measures

    1. Complete clinical remission of the warts [30 days]

      Number of warts (counts)

    2. Clinical assessment of warts curement [30 days]

      Diameter of wart in cm

    Secondary Outcome Measures

    1. Pain asssesment [30 days]

      pain was assesed by VAS scoring (0) the least to (5) highest

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soad A. Mohamad Minya Egypt 05673

    Sponsors and Collaborators

    • Deraya University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soad Ali, lecturer of pharmaceutics and clinical pharmacy Deraya university, Deraya University
    ClinicalTrials.gov Identifier:
    NCT05592041
    Other Study ID Numbers:
    • Anti-HPV
    First Posted:
    Oct 24, 2022
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Warts
    Foot Diseases

    Study Results

    No Results Posted as of Jan 25, 2023