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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210730052027N1

Enrollment

Registered

2021-08-26

Start date

2021-08-16

Completion date

Unknown

Last updated

2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: 25 patients diagnosed with PCOS based on the Rotterdam Criteria will take 15 mg of Crosina (Saffron as an active ingredient) once a day and metformin 500 mg three t

Eligibility

Sex/Gender

Female

Age

18 Years to 44 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhdieh Asadi

Yazd University of Medical Sciences

asadiahdie@gmail.com+98 35 3820 3419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026