Aqueous Mushroom Extract and Intraocular Pressure (AME)
Primary Purpose
Glaucoma
Status
Unknown status
Phase
Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
OME
OME
OME
OME
OME
OME
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring GLAUCOMA
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of open angle glaucoma
- intraocular pressure above 23mmHg
Exclusion Criteria:
- close angle glaucoma
- end stage of glaucoma visual field loss
- ocular disease other than glaucoma that will interfere with result
Sites / Locations
- Eye Clinic University of Benin Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
A1 (glaucoma)
A2 (glaucoma)
A3 (glaucoma)
A1 (normals)
A2 (normals)
A3 (normals)
Arm Description
Outcomes
Primary Outcome Measures
DECREASE INTRA OCULAR PRESSURE
Secondary Outcome Measures
Full Information
NCT ID
NCT01017068
First Posted
November 19, 2009
Last Updated
November 23, 2009
Sponsor
University of Benin
1. Study Identification
Unique Protocol Identification Number
NCT01017068
Brief Title
Aqueous Mushroom Extract and Intraocular Pressure
Acronym
AME
Official Title
Aqueous Mushroom Extract as a Glaucoma Agent
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
February 2010 (Anticipated)
Study Completion Date
February 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Benin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effect of Aqueous mushroom extract (AME) on intra ocular pressure (IOP) in humans or as a potential anti glaucoma drug.
Detailed Description
The Prophet of Islam (Peace Be On Him) was reported to have said that 'mushroom are like manna and their water heals eye diseases'(Sahih Bukhari 1985). This statement is being investigated in view of the link between blood pressure and intra ocular pressure.
Glaucoma which is a sight threatening disease and is associated with raised intraocular pressure has been treated for a long time with beta blockers. Nowadays the drugs of choice are prostaglandin analogs. This study seeks to discover the effect of pleurotus tuberregium on raised intraocular pressure and to compare its effect on I.O.P with that of known glaucoma drugs. This study also seeks to find out at what concentration pleurotus is effective significantly on raised intraocular pressure
Clinical Investigation will be conducted in the Ophthalmological unit of UBTH in two phases. In the first phase 21 relatively young healthy subjects aged less than 50 yrs will be recruited for this study after their informed consent. They will have no previous systemic or ocular diseases and have an intraocular pressure of 19mmHg or less and a visual acuity of 6/6. Base line investigations will include the systolic and diastolic blood pressure, horizontal pupillary diameter and applanation tonometry. The subjects will be divided into three groups of seven each (A1, A2 and A3).
The study will at first constitute two weeks mushroom treatment, two weeks no mushroom treatment and then two weeks mushroom treatment. Treatment will be with aqueous extract of Oyster Medicinal mushroom Extract (4g/100ml) dose: п gutt tid x 1/52 for A1, 2g/100ml dose: п gutt tid x 1/52 for A2 and 1g/100ml dose: п gutt tid x 1/52 for A3. Investigations of the baseline parameters will be done at the start and after each seven days. The subjects will be monitored to ensure full compliance with the designed protocol.
The second phase will involve an equal number of age matched ocular hypertensive or glaucoma patient undergoing treatment in UBTH. They will also be divided into three groups of seven each and the treatment regimen above repeated. The IOP in this case will be taken by a masked observer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
GLAUCOMA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A1 (glaucoma)
Arm Type
Experimental
Arm Title
A2 (glaucoma)
Arm Type
Experimental
Arm Title
A3 (glaucoma)
Arm Type
Experimental
Arm Title
A1 (normals)
Arm Type
Experimental
Arm Title
A2 (normals)
Arm Type
Experimental
Arm Title
A3 (normals)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OME
Intervention Description
4g/100ml) dose: п gutt tid x 1/52
Intervention Type
Drug
Intervention Name(s)
OME
Intervention Description
(2g/100ml) dose: п gutt tid x 1/52
Intervention Type
Drug
Intervention Name(s)
OME
Intervention Description
(1g/100ml) dose: п gutt tid x 1/52
Intervention Type
Drug
Intervention Name(s)
OME
Intervention Description
(4g/100ml) dose: п gutt tid x 1/52
Intervention Type
Drug
Intervention Name(s)
OME
Intervention Description
(2g/100ml) dose: п gutt tid x 1/52
Intervention Type
Drug
Intervention Name(s)
OME
Intervention Description
(1g/100ml) dose: п gutt tid x 1/52
Primary Outcome Measure Information:
Title
DECREASE INTRA OCULAR PRESSURE
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of open angle glaucoma
intraocular pressure above 23mmHg
Exclusion Criteria:
close angle glaucoma
end stage of glaucoma visual field loss
ocular disease other than glaucoma that will interfere with result
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GHALIB A AKINLABI, OD, MSc.
Phone
+2348055200834
Email
gaakinlabi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
VINCENT I IYAWE, MD, PhD
Organizational Affiliation
University of Benin, Benin City Nigeria
Official's Role
Study Chair
Facility Information:
Facility Name
Eye Clinic University of Benin Teaching Hospital
City
Benin City
State/Province
Edo
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omolabake T Edema, MD
12. IPD Sharing Statement
Citations:
Citation
Akinlabi GA, Igbinigie EV, Akpaja EO, Iyawe VI. Preliminary study on the effect of medicinal mushroom extract and timolol maleate on dexamethasone induced ocular hypertension in feline's eye model.Journal of Medicine and Biomedical Research 6(2)63-68. Akinlabi GA, Uzibor HI, Iyawe IO, Iyawe VI. Effect of oyster mushroom exract(pleurotus ostreatus) and latanoprost on intra ocular pressure using cat's eye model. Journal of Medicine and Biomedical Research 8(1)58-64.
Results Reference
background
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Aqueous Mushroom Extract and Intraocular Pressure
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