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Recruiting NCT07366944

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

No phase Interventional Polycystic Ovary Syndrome Dry Eye Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exercise and limiting diet, diet limitation.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome, Dry Eye, Obesity. Basic parameters: 30 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Detailed description

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.

Interventions

  • Behavioral exercise and limiting diet
    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.
  • Behavioral diet limitation
    twenty females with PCOS, eye dryness , and obesity will receive metformin thrice times daily and low calorie diet for 12 weeks.

Primary outcome measures

  • schrimer test [Time frame: it will be measured after 12 weeks]
Secondary outcome measures (9)
  • Ocular surface disability index [Time frame: It will be measured after 12 weeks]
  • dry eye scoring system [Time frame: It will be measured after 12 weeks]
  • Tear film break-up time [Time frame: It will be measured after 12 weeks]
  • body mass index [Time frame: it will be measured after 12 weeks]
  • wasit hip ratio [Time frame: It will be measured after 12 weeks]
  • wasit circumference [Time frame: It will be measured after 12 weeks]
  • testesterone [Time frame: It will be measured after 12 weeks]
  • LH:FSH ratio [Time frame: It will be measured after 12 weeks]
  • dehydroepiandrosterone [Time frame: It will be measured after 12 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • liver disoease
  • cardiac disease
  • renal disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Giza

Identifiers

NCT: NCT07366944 · IRB000-14233-63

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗