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临床试验/NCT07366944
NCT07366944招募中不适用

PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes in Obese Women

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
schrimer test

研究概览

简要总结

Women with polycystic ovarian syndrome (PCOS) may complain dryness of their eyes especially obese ones. lifestye changes are main treatrment fro both problems

详细描述

Forty females with PCOS, eye dryness , and obesity will asigned to group I or Group II, n=20 for each group. Both groups will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • PCOS women
  • obese class I
  • bilateral dryness of eye

排除标准

  • liver disoease
  • cardiac disease
  • renal disease

研究组 & 干预措施

group number 1

Experimental

twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks. Group I, additionally will perform one hour of treadmill walking thrice weekly for 12 weeks.

干预措施: exercise and limiting diet (Behavioral)

group number 2

Active Comparator

Twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.

干预措施: diet limitation (Behavioral)

结局指标

主要结局

schrimer test

时间窗: it will be measured after 12 weeks

it is a test for assessment dye dryness

次要结局

  • Ocular surface disability index(It will be measured after 12 weeks)
  • dry eye scoring system(It will be measured after 12 weeks)
  • Tear film break-up time(It will be measured after 12 weeks)
  • body mass index(it will be measured after 12 weeks)
  • wasit hip ratio(It will be measured after 12 weeks)
  • wasit circumference(It will be measured after 12 weeks)
  • testesterone(It will be measured after 12 weeks)
  • LH:FSH ratio(It will be measured after 12 weeks)
  • dehydroepiandrosterone(It will be measured after 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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