Glucosamine Sulphate and Ginkgo Biloba as Antifungal Activity for Treating Tinea Pedis

October 9, 2019 updated by: Ahmed A. H. Abdellatif

Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ginko Biloba (GKB) & Glucosamine (GL) were formulated in different dosage forms such as capsules, hydrogel and spray. GKB&GL were in filled in hard gelatin capsules as three formulae (GKB caps, GL caps and both as mixture in caps). Also, GKB&GL were formulated in hydrogel using 2% carbopol 934 as three formulae (GKB only, GL only and both as mixture). The same also were formulated as spray using alcohol, water and glycerol in concentration of 60%, 20% and 20% respectively. The study included 5 trials, involving 35 participants. The oral formulae were tried on 30 participants having Tenia Pedis. Fluconazole was as standard antifungal drug.The antifungal activity of all gel formulae was determined by Agar well-diffusion method. It is also important to follow up and collect data, preferably for six months for local and systemic activity, to establish whether or not the infection recurred or not. In future clinical trials, research should consider the costs of the different treatment approaches.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • 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
      • Assiut, Egypt, 71526
        • Recruiting
        • Assiut Clinic
        • Contact:
          • Ahmed AH Abdellatif, PhD

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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
Active Comparator: Infected group
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms.
Drug: infected group
Ginkgo Biloba in different dosage forms
Other Names:
  • Body Spray
Placebo Comparator: Control group
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba.
Drug: control group
placebo without Ginkgo Biloba
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment the antifungal activity of Ginkgo Biloba & Glucosamine
Time Frame: six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability test for different dosage forms
Time Frame: three months
Stability test will be studied for dosage forms. The test will carried out by standing the products on shelf life for three months. The stability test will be recorded using high performance liquid chromatography each thee days.
three months

Collaborators and Investigators

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

Sponsor

Ahmed A. H. Abdellatif

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 10, 2019

Last Update Submitted That Met QC Criteria

October 9, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlAzharGGATP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Foot Infection Tinea Pedis

Clinical Trials on infected group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe