Evaluation of therapeutic effects of crocina (saffron tablets) in patients with polycystic ovary syndrome: a randomized double-blind clinical trial

Phase 2

Recruiting

Conditions: Polycystic ovary syndrome.
Polycystic ovarian syndrome
E28.2

Registration Number: IRCT20210730052027N1

Lead Sponsor: Yazd University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

Age 18 to 44 years
Adequate literacy to understand the study, drug use and potential side effects
Patient known with polycystic ovary syndrome

Exclusion Criteria

Serious medical conditions that the patient cannot regularly attend periodic visits include severe cardiovascular disease such as angina or myocardial infarction, recent stroke, psychiatric disorders, active concussion, and anemia
Taking estrogenic or progestin drugs to regulate the monthly cycle
Antidepressants (SSRI, SNRI, TCA, MAOI6)
Failure to sign written consent
Pregnancy and lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in Serum Levels of Gonadotropins (LH and FSH) Dihydroepiandrosterone Dione (DHEA) Fasting Blood Glucose. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Blood sample.;Measuring fasting blood sugar. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Blood sample.;Changes in Serum Levels of Dihydroepiandrosterone Dione (DHEA). Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Blood sample.

Secondary Outcome Measures

Name	Time	Method
Body Mass Index. Timepoint: Before the intervention, after completion of the intervention. Method of measurement: Based on the Body Mass Index.;Hirsutism. Timepoint: At the beginning of the study and at 15,30,45,60,75,90 days after the intervention. Method of measurement: Clinical case and Ferriman-Galwey criteria and also subjectively as a patient self-report for improved hirsutism with the modified (Dermatology Quality of Life Index).