Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
42 participants
INTERVENTIONAL
2009-11-30
2010-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A1 (glaucoma)
OME
4g/100ml) dose: п gutt tid x 1/52
A2 (glaucoma)
OME
(2g/100ml) dose: п gutt tid x 1/52
A3 (glaucoma)
OME
(1g/100ml) dose: п gutt tid x 1/52
A1 (normals)
OME
(4g/100ml) dose: п gutt tid x 1/52
A2 (normals)
OME
(2g/100ml) dose: п gutt tid x 1/52
A3 (normals)
OME
(1g/100ml) dose: п gutt tid x 1/52
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OME
4g/100ml) dose: п gutt tid x 1/52
OME
(2g/100ml) dose: п gutt tid x 1/52
OME
(1g/100ml) dose: п gutt tid x 1/52
OME
(4g/100ml) dose: п gutt tid x 1/52
OME
(2g/100ml) dose: п gutt tid x 1/52
OME
(1g/100ml) dose: п gutt tid x 1/52
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* intraocular pressure above 23mmHg
Exclusion Criteria
* end stage of glaucoma visual field loss
* ocular disease other than glaucoma that will interfere with result
18 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Benin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dean, College of Basic Medical Sciences. UNIBEN.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
VINCENT I IYAWE, MD, PhD
Role: STUDY_CHAIR
University of Benin, Benin City Nigeria
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eye Clinic University of Benin Teaching Hospital
Benin City, Edo, Nigeria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRLLSAW
Identifier Type: -
Identifier Source: org_study_id