Aqueous Mushroom Extract and Intraocular Pressure

Glaucoma Clinical Trial

— AME  

Official title:

Aqueous Mushroom Extract as a Glaucoma Agent

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01017068
• Other study ID #: MRLLSAW
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 19, 2009
• Last updated: November 23, 2009
• Start date: November 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2009
• Source: University of Benin
• Contact: GHALIB A AKINLABI, OD, MSc.
• Phone: +2348055200834
• Email: gaakinlabi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Nigeria: The National Agency for Food and Drug Administration and Control
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• OME
4g/100ml) dose: ? gutt tid x 1/52
• OME
(2g/100ml) dose: ? gutt tid x 1/52
• OME
(1g/100ml) dose: ? gutt tid x 1/52
• OME
(4g/100ml) dose: ? gutt tid x 1/52
• OME
(2g/100ml) dose: ? gutt tid x 1/52
• OME
(1g/100ml) dose: ? gutt tid x 1/52

Locations

Country	Name	City	State
Nigeria	Eye Clinic University of Benin Teaching Hospital	Benin City	Edo

Sponsors (1)

Lead Sponsor	Collaborator
University of Benin

Country where clinical trial is conducted

Nigeria, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DECREASE INTRA OCULAR PRESSURE		3 months	No