Aqueous Mushroom Extract and Intraocular Pressure (AME)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by University of Benin.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Benin
ClinicalTrials.gov Identifier:
NCT01017068
First received: November 19, 2009
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Glaucoma
Drug: OME
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aqueous Mushroom Extract as a Glaucoma Agent

Resource links provided by NLM:


Further study details as provided by University of Benin:

Primary Outcome Measures:
  • DECREASE INTRA OCULAR PRESSURE [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: November 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017068

Contacts
Contact: GHALIB A AKINLABI, OD, MSc. +2348055200834 gaakinlabi@yahoo.com

Locations
Nigeria
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
Investigators
Study Chair: VINCENT I IYAWE, MD, PhD University of Benin, Benin City Nigeria
  More Information

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.

Responsible Party: Prof. V.I, Iyawe, Dean, College of Basic Medical Sciences. UNIBEN.
ClinicalTrials.gov Identifier: NCT01017068     History of Changes
Other Study ID Numbers: MRLLSAW
Study First Received: November 19, 2009
Last Updated: November 23, 2009
Health Authority: Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by University of Benin:
GLAUCOMA

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014