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临床试验/NCT01017068
NCT01017068Unknown1 期

Aqueous Mushroom Extract as a Glaucoma Agent

University of Benin1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
42
试验地点
1
主要终点
DECREASE INTRA OCULAR PRESSURE

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

A1 (glaucoma)

Experimental

干预措施: OME (Drug)

A2 (glaucoma)

Experimental

干预措施: OME (Drug)

A3 (glaucoma)

Experimental

干预措施: OME (Drug)

A1 (normals)

Experimental

干预措施: OME (Drug)

A2 (normals)

Experimental

干预措施: OME (Drug)

A3 (normals)

Experimental

干预措施: OME (Drug)

结局指标

主要结局

DECREASE INTRA OCULAR PRESSURE

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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