Aqueous Mushroom Extract and Intraocular Pressure (AME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01017068
Recruitment Status : Unknown
Verified November 2009 by University of Benin.
Recruitment status was:  Not yet recruiting
First Posted : November 20, 2009
Last Update Posted : November 25, 2009
Information provided by:
University of Benin

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: OME Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aqueous Mushroom Extract as a Glaucoma Agent
Study Start Date : November 2009
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A1 (glaucoma) Drug: OME
4g/100ml) dose: п gutt tid x 1/52
Experimental: A2 (glaucoma) Drug: OME
(2g/100ml) dose: п gutt tid x 1/52
Experimental: A3 (glaucoma) Drug: OME
(1g/100ml) dose: п gutt tid x 1/52
Experimental: A1 (normals) Drug: OME
(4g/100ml) dose: п gutt tid x 1/52
Experimental: A2 (normals) Drug: OME
(2g/100ml) dose: п gutt tid x 1/52
Experimental: A3 (normals) Drug: OME
(1g/100ml) dose: п gutt tid x 1/52

Primary Outcome Measures :
  1. DECREASE INTRA OCULAR PRESSURE [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01017068

Contact: GHALIB A AKINLABI, OD, MSc. +2348055200834

Eye Clinic University of Benin Teaching Hospital Not yet recruiting
Benin City, Edo, Nigeria
Principal Investigator: Omolabake T Edema, MD         
Sponsors and Collaborators
University of Benin
Study Chair: VINCENT I IYAWE, MD, PhD University of Benin, Benin City Nigeria

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.

Responsible Party: Prof. V.I, Iyawe, Dean, College of Basic Medical Sciences. UNIBEN. Identifier: NCT01017068     History of Changes
Other Study ID Numbers: MRLLSAW
First Posted: November 20, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by University of Benin:

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases