The effect of Vitex agnus_castus plant in women with polycystic ovary syndrome

The effect of Vitex agnus_castus plant on some marker of oxidative stress, lipid profile and insulin resistance in women with polycystic ovary syndrome: A randomized double blind clinical trial study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230222057493N1

Enrollment

Registered

2023-03-28

Start date

2023-04-03

Completion date

Unknown

Last updated

2025-07-21

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: Agnugol tablet (a coated tablet containing the dry extract of the Vitex agnus_castus plant in the amount of 2.3-8.4 mg and an average of 5.35 mg, standardized to 0

Eligibility

Sex/Gender

Female

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women in the age range of 18-45 years Confirmation of PCOS by a specialist doctor, based on Rotterdam criteria Patient satisfaction to enter the study Patients who do not intend to become pregnant because the profile of therapeutic drugs for people who intend to become pregnant is different from those who do not intend to become pregnant

Exclusion criteria

Exclusion criteria: Smoking Thyroid disorders Hyperprolactinemia Diabetes Pregnancy Consumption of dopamine antagonists Consumption of antioxidant supplements Breastfeeding

Design outcomes

Primary

Measure	Time frame
High density lipoprotein (HDL-C). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Spectrophotometry.;Low-density lipoprotein(LDL-C). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Triglyceride. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Fasting glucose. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Catalase. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Insulin resistance. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: HOMA-IR model evaluation.;Reduced Glutathione. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Glutathione peroxidase. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Total Thiol. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Aspartate aminotransferase(AST). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Alanine aminotransferase(ALT). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Number of periods. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months).;The rate of hirsutism. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Ferriman_gallway score.;Insulin. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA.;Cholesterol. Timepoint: Before and 12 weeks after the sta	—

Measure

Time frame

High density lipoprotein (HDL-C). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Spectrophotometry.;Low-density lipoprotein(LDL-C). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Triglyceride. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Fasting glucose. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Catalase. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Insulin resistance. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: HOMA-IR model evaluation.;Reduced Glutathione. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Glutathione peroxidase. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Total Thiol. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Aspartate aminotransferase(AST). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Alanine aminotransferase(ALT). Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Colorimetric.;Number of periods. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: To ask the patient and dividing the total number of menstruations that occurred in three months by the expected number of menstruations (three times in three months).;The rate of hirsutism. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: Ferriman_gallway score.;Insulin. Timepoint: Before and 12 weeks after the start of the intervention. Method of measurement: ELISA.;Cholesterol. Timepoint: Before and 12 weeks after the sta

—

Secondary

Measure	Time frame
Body mass index (BMI). Timepoint: Before and after 12 weeks of intervention. Method of measurement: Weight /( height)^2.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAniseh Hatami

Arak University of Medical Sciences

Aniseh.hatami@yahoo.com+98 86 3417 3645

Outcome results

None listed

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