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

Foot Infection Tinea Pedis Clinical Trial

Official title:

Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882438
• Other study ID #: AlAzharGGATP
• Status: Recruiting
• Phase: Phase 1
• Start date: January 2016
• Est. completion date: October 2022

Study information

• Verified date: October 2019
• Source: Al-Azhar University
• Contact: Ahmed A. H. Abdellatif, phD
• Phone: +201016660069
• Email: ahmed.a.h.abdellatif[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2022
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Foot Infection Tinea Pedis
• Tinea
• Tinea Pedis

Intervention

Drug:
• infected group
Ginkgo Biloba in different dosage forms
• control group
placebo without Ginkgo Biloba

Locations

Country	Name	City	State
Egypt	Assiut Clinic	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed A. H. Abdellatif

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Täuber A, Müller-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. I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stability test for different dosage forms	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