NCT01017068

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

3 months

First QC Date

November 19, 2009

Last Update Submit

November 23, 2009

Conditions

Glaucoma

Keywords

GLAUCOMA

Outcome Measures

Primary Outcomes (1)

  • DECREASE INTRA OCULAR PRESSURE

    3 months

Study Arms (6)

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

Interventions

OMEDRUG

4g/100ml) dose: п gutt tid x 1/52

A1 (glaucoma)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of open angle glaucoma
  • intraocular pressure above 23mmHg

You may not qualify if:

  • close angle glaucoma
  • end stage of glaucoma visual field loss
  • ocular disease other than glaucoma that will interfere with result

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Clinic University of Benin Teaching Hospital

Benin City, Edo, Nigeria

Location

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • VINCENT I IYAWE, MD, PhD

    University of Benin, Benin City Nigeria

    STUDY CHAIR

Central Study Contacts

GHALIB A AKINLABI, OD, MSc.

CONTACT

+2348055200834gaakinlabi@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 20, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

NG(1)