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

Sponsor
Ahmed A. H. Abdellatif (Other)
Overall Status
Recruiting
CT.gov ID
NCT02882438
Collaborator
(none)
30
1
2
81
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Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut Clinic Assiut Egypt 71526

    Sponsors and Collaborators

    • Ahmed A. H. Abdellatif

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed A. H. Abdellatif, phD and Lectrurer, Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Al-Azhar University
    ClinicalTrials.gov Identifier:
    NCT02882438
    Other Study ID Numbers:
    • AlAzharGGATP
    First Posted:
    Aug 29, 2016
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 10, 2019