Glucosamine Sulphate and Ginkgo Biloba as Antifungal Activity for Treating Tinea Pedis
Primary Purpose
Foot Infection Tinea Pedis
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
infected group
control group
Sponsored by
About this trial
This is an interventional treatment trial for Foot Infection Tinea Pedis
Eligibility 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.
Sites / Locations
- Assiut ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Infected group
Control group
Arm Description
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms.
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02882438
First Posted
November 26, 2015
Last Updated
October 9, 2019
Sponsor
Ahmed A. H. Abdellatif
1. Study Identification
Unique Protocol Identification Number
NCT02882438
Brief Title
Glucosamine Sulphate and Ginkgo Biloba as Antifungal Activity for Treating Tinea Pedis
Official Title
Glucosamine Sulphate and Ginkgo Biloba for Treating Tinea Pedis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed A. H. Abdellatif
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Infection Tinea Pedis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Infected group
Arm Type
Active Comparator
Arm Description
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received Ginkgo Biloba in different dosage forms.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
A group of volunteers infected with Tinea pedis, Capitis and Versicolor received placebo without Ginkgo Biloba.
Intervention Type
Drug
Intervention Name(s)
infected group
Other Intervention Name(s)
Body Spray
Intervention Description
Ginkgo Biloba in different dosage forms
Intervention Type
Drug
Intervention Name(s)
control group
Other Intervention Name(s)
placebo
Intervention Description
placebo without Ginkgo Biloba
Primary Outcome Measure Information:
Title
Assessment the antifungal activity of Ginkgo Biloba & Glucosamine
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Stability test for different dosage forms
Description
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.
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A. H. Abdellatif, phD
Phone
+201016660069
Email
ahmed.a.h.abdellatif@azhar.edu.eg
Facility Information:
Facility Name
Assiut Clinic
City
Assiut
ZIP/Postal Code
71526
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed AH Abdellatif, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26276254
Citation
Tauber A, Muller-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. Int J Pharm. 2015 Oct 15;494(1):304-11. doi: 10.1016/j.ijpharm.2015.08.023. Epub 2015 Aug 11.
Results Reference
result
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Glucosamine Sulphate and Ginkgo Biloba as Antifungal Activity for Treating Tinea Pedis
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