Effect of saffron and vitamin E in polycystic ovary syndrome

Phase 3

Recruiting

• Conditions: polycystic ovary syndrome.; Polycystic ovarian syndrome; E28.2

• Registration Number: IRCT20191105045340N4
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

Women express their satisfaction by completing a written form to participate in the study.
2- Diagnosis of polycystic ovary syndrome based on the diagnosis of a gynecologist and having PCOS diagnostic criteria according to the guidelines of the American Association for Reproduction (Rotterdam criteria, 2003 which required at least 2 of the following 3 criteria: 1) oligo and/or Absence of ovulation 2) Clinical or biochemical signs of hyperandrogenism and 3) morphology of polycystic ovary shown in ultrasound examination).
Women should be between the ages of 18 and 45
People's BMI should be in the range of 25 to 35.

Exclusion Criteria

A history of chronic diseases including diabetes, liver disease, thyroid, cardiovascular and kidney diseases, and endometriosis.
Having other disorders that resemble PCOS, including hyperprolactinemia, late-onset congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome.
Following a special diet and exercise
Use of insulin and insulin sensitizers and other glucose-lowering drugs, contraceptives, weight loss agents and anti-inflammatory drugs.
Smoking and alcohol consumption in less than 1 month
Using any food supplements and antioxidants in the last 1 month
Pregnancy and breastfeeding

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin. Timepoint: before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Chemiluminescence immunoassay(CLIA).;Dehydroepiandrosterone. Timepoint: before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: CLIA.;Hirsutism. Timepoint: before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Ferriman–Gallwey index.