The Effect of Evening Primrose Oil on Clinical Symptoms in Women with Polycystic Ovary Syndrome

Phase 3

Recruiting

Conditions: Polycystic Ovary Syndrome (PCOS).
Polycystic ovarian syndrome
E28.2

Registration Number: IRCT20120718010324N73

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 62

Inclusion Criteria

Confirmation of the diagnosis of PCOS according to the criteria of the Androgen Excess/PCOS Society, including anovulation, chronic low ovulation, or polycystic ovaries and clinical or biochemical signs of hyperandrogenism
Minimum hirsutism score of 6 with the Freeman Galloway criterion
Having literacy to complete the questionnaires
BMI between 18.5 and 40
Ages 18-45 years
Not taking vitamins, minerals and omega-6 in the three months before the intervention

Exclusion Criteria

Having other androgenic disorders such as adrenal hyperplasia or androgen-producing tumor
Having Cushing's syndrome
Having thyroid gland diseases
Pregnancy or breastfeeding
Women undergoing infertility treatment at the time of the study
Previous surgery on one or both ovaries
Consumption of dietary supplements
Smoking and alcohol consumption
Occurrence of unfortunate events

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hirsutism score. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Ferriman – Gallwey index.;Depression symptoms score. Timepoint: Before the intervention and after the end of intervention. Method of measurement: Beck Depression Inventory.

Secondary Outcome Measures

Name	Time	Method
Frequency of adverse events in the study groups. Timepoint: During the intervention. Method of measurement: Researcher-made checklist.;Anthropometric indices (waist circumference, hip circumference, BMI). Timepoint: Before and after the intervention. Method of measurement: Checklist of anthropometric indices.;Menstrual disorders. Timepoint: Before and after the intervention. Method of measurement: Menstrual characteristics questionnaire.