NCT05592041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

October 17, 2022

Last Update Submit

May 15, 2024

Conditions

Plantar Wart

Outcome Measures

Primary Outcomes (2)

  • Complete clinical remission of the warts

    Number of warts (counts)

    30 days

  • Clinical assessment of warts curement

    Diameter of wart in cm

    30 days

Secondary Outcomes (1)

  • Pain asssesment

    30 days

Study Arms (2)

Treatment group (Group I)

EXPERIMENTAL
Drug: Banaba Leaf Extract

Control group (Group II)

NO INTERVENTION

Interventions

Banaba Leaf ExtractDRUG

a herbal extract in the form of Bigel

Also known as: moringa banna nigella
Treatment group (Group I)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patient suspected to be immunocompromised
  • Patient aged under 18 years
  • Patient refusing to sign the consent
  • Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad A. Mohamad

Minya, 05673, Egypt

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of pharmaceutics and clinical pharmacy Deraya university

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 24, 2022

Study Start

October 20, 2022

Primary Completion

December 18, 2022

Study Completion

January 10, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

EG(1)