GlaucomaPhase 1/2AMENCT01017068
Aqueous Mushroom Extract and Intraocular Pressure
A Phase 1/2 study testing OME in people with Glaucoma, run by University of Benin at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- OME
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNigeria
- Study dates
- Nov 2009to Feb 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinical diagnosis of open angle glaucoma
- intraocular pressure above 23mmHg
Who cannot join
- close angle glaucoma
- end stage of glaucoma visual field loss
- ocular disease other than glaucoma that will interfere with result
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Eye Clinic University of Benin Teaching Hospital
Benin City, Edo
Omolabake T Edema, MD
About this study
Official title: Aqueous Mushroom Extract as a Glaucoma Agent
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- OME
- Keywords
- GLAUCOMA
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMEDrug
4g/100ml) dose: п gutt tid x 1/52
OMEDrug
(2g/100ml) dose: п gutt tid x 1/52
OMEDrug
(1g/100ml) dose: п gutt tid x 1/52
OMEDrug
(4g/100ml) dose: п gutt tid x 1/52
OMEDrug
(2g/100ml) dose: п gutt tid x 1/52
OMEDrug
(1g/100ml) dose: п gutt tid x 1/52
| Study group | Role | What they receive |
|---|---|---|
| A1 (glaucoma) | Experimental | Not described Receives: Drug: OME |
| A2 (glaucoma) | Experimental | Not described Receives: Drug: OME |
| A3 (glaucoma) | Experimental | Not described Receives: Drug: OME |
| A1 (normals) | Experimental | Not described Receives: Drug: OME |
| A2 (normals) | Experimental | Not described Receives: Drug: OME |
| A3 (normals) | Experimental | Not described Receives: Drug: OME |
What is being measured
The primary outcome is the main question the study is designed to answer.
DECREASE INTRA OCULAR PRESSURE
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2010 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Benin
- Sponsor type
- University, hospital or other
- Investigators
- VINCENT I IYAWE, MD, PhD, Study chair, University of Benin, Benin City Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01017068
- Sponsor's protocol ID
- MRLLSAW
- Acronym
- AME
- Status last verified
- Nov 2009
- First submitted
- 19 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aqueous Mushroom Extract as a Glaucoma Agent
- ClinicalTrials.gov ID
- NCT01017068
- Acronym / sponsor ID
- AME / MRLLSAW
- Conditions
- Glaucoma
- Keywords
- GLAUCOMA
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of BeninUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1 (glaucoma) | Experimental | Drug: OME |
| A2 (glaucoma) | Experimental | Drug: OME |
| A3 (glaucoma) | Experimental | Drug: OME |
| A1 (normals) | Experimental | Drug: OME |
| A2 (normals) | Experimental | Drug: OME |
| A3 (normals) | Experimental | Drug: OME |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of open angle glaucoma
- intraocular pressure above 23mmHg
Key exclusion criteria (3 listed)
- close angle glaucoma
- end stage of glaucoma visual field loss
- ocular disease other than glaucoma that will interfere with result
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OME4g/100ml) dose: п gutt tid x 1/52 | Drug | A1 (glaucoma) |
| OME(2g/100ml) dose: п gutt tid x 1/52 | Drug | A2 (glaucoma) |
| OME(1g/100ml) dose: п gutt tid x 1/52 | Drug | A3 (glaucoma) |
| OME(4g/100ml) dose: п gutt tid x 1/52 | Drug | A1 (normals) |
| OME(2g/100ml) dose: п gutt tid x 1/52 | Drug | A2 (normals) |
| OME(1g/100ml) dose: п gutt tid x 1/52 | Drug | A3 (normals) |
Primary outcome
DECREASE INTRA OCULAR PRESSURE
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2009.
- BackgroundAkinlabi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VINCENT I IYAWE, MD, PhD study chair
University of Benin, Benin City Nigeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OME in people with Glaucoma, run by University of Benin at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GHALIB A AKINLABI, OD, MSc. (+2348055200834, gaakinlabi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DECREASE INTRA OCULAR PRESSURE (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01017068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2009.