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

Phase 1

• Conditions: Foot Infection Tinea Pedis
• Interventions: Drug: infected group; Drug: control group

• Registration Number: NCT02882438
• Lead Sponsor: Ahmed A. H. Abdellatif

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.

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 Timeline

• Study First Submitted: 2015-11-26
• Study Start: 2016-01
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-08-29
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-10
• Primary Completion: 2020-09
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infected group	infected group	A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms.
Control group	control group	A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba.

Primary Outcome Measures

Name	Time	Method
Assessment the antifungal activity of Ginkgo Biloba & Glucosamine	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.

Secondary Outcome Measures

Name	Time	Method
Stability test for different dosage forms	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.

Trial Locations

Locations (1)

Assiut Clinic; 🇪🇬 Assiut, Egypt