NCT02882438

Brief Summary

Tinea Pedis infected the feet of about 20-25% of the world population. Tinea Pedis is a fungal infection of the feet and it is easily spread. Oral therapy is usually used for chronic conditions or when topical treatment has failed. The aim of this study is to prove the antifungal and antibacterial activity of Ginko Biloba (GKB) \& Glucosamine (GL) as separate material or both in combination.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

4.7 years

First QC Date

November 26, 2015

Last Update Submit

October 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment the antifungal activity of Ginkgo Biloba & Glucosamine

    Ginkgo Biloba and Glucosamine will be applied with infected patients even systemically or topically. The results will be compared with control groups to prove the Antifungal Activity.

    six months

Secondary Outcomes (1)

  • Stability test for different dosage forms

    three months

Study Arms (2)

Infected group

ACTIVE COMPARATOR

A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms.

Drug: infected group

Control group

PLACEBO COMPARATOR

A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba.

Drug: control group

Interventions

Ginkgo Biloba in different dosage forms

Also known as: Body Spray
Infected group

placebo without Ginkgo Biloba

Also known as: placebo
Control group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • It is important to follow up and collect data, preferably for six months for local and systemic activity of Ginkgo Biloba and Glucosamine, to establish whether the infection recurrent or not.

You may not qualify if:

  • Larger numbers of participants having different kind of fungal infection are needed to test efficiency drug in order to produce more reliable data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut Clinic

Asyut, 71526, Egypt

RECRUITING

Related Publications (1)

  • Tauber A, Muller-Goymann CC. In vitro model of infected stratum corneum for the efficacy evaluation of poloxamer 407-based formulations of ciclopirox olamine against Trichophyton rubrum as well as differential scanning calorimetry and stability studies. Int J Pharm. 2015 Oct 15;494(1):304-11. doi: 10.1016/j.ijpharm.2015.08.023. Epub 2015 Aug 11.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Ahmed A. H. Abdellatif, phD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
phD and Lectrurer, Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy

Study Record Dates

First Submitted

November 26, 2015

First Posted

August 29, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2020

Study Completion

October 1, 2022

Last Updated

October 10, 2019

Record last verified: 2019-10

Locations