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

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ClinicalTrials.gov Identifier: NCT02882438
Recruitment Status : Recruiting
First Posted : August 29, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed A. H. Abdellatif, Al-Azhar University

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.

Condition or disease Intervention/treatment Phase
Foot Infection Tinea Pedis Drug: infected group Drug: control group Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis
Study Start Date : January 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882438


Contacts
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Contact: Ahmed A. H. Abdellatif, phD +201016660069 ahmed.a.h.abdellatif@azhar.edu.eg

Locations
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Egypt
Assiut Clinic Recruiting
Assiut, Egypt, 71526
Contact: Ahmed AH Abdellatif, PhD         
Sponsors and Collaborators
Ahmed A. H. Abdellatif

Publications of Results:
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Responsible Party: Ahmed A. H. Abdellatif, phD and Lectrurer, Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02882438     History of Changes
Other Study ID Numbers: AlAzharGGATP
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms