Ignite Creation Date:
2024-05-05 @ 10:02 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01017068
Status:
UNKNOWN
Last Update Posted:
2009-11-25
First Post:
2009-11-19
Brief Title:
Aqueous Mushroom Extract and Intraocular Pressure
Sponsor:
University of Benin
Organization:
University of Benin
Study Overview
Official Title:
Aqueous Mushroom Extract as a Glaucoma Agent
Status:
UNKNOWN
Status Verified Date:
2009-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AME
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 diseasesSahih 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 IOP 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 66 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 4g100ml dose п gutt tid x 152 for A1 2g100ml dose п gutt tid x 152 for A2 and 1g100ml dose п gutt tid x 152 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
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 IOP 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 66 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 4g100ml dose п gutt tid x 152 for A1 2g100ml dose п gutt tid x 152 for A2 and 1g100ml dose п gutt tid x 152 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None