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The effect of berberine supplementation on individuals with polycystic ovary syndrome: a randomized controlled clinical trial study.

"The effect of Berberine supplementation on improving metabolic and hormonal indices in women with polycystic ovary syndrome: a randomized controlled clinical trial"

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250216064738N1
Enrollment
40
Registered
2025-02-22
Start date
2025-02-28
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.

Interventions

Intervention 1: Intervention group: Received oral Berberine at a dose of 300 mg, four times a day for at least 2 months. The drug was purchased from Fazl Darou Pharmaceutical Company under the brand n

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women aged 18 to 45 Diagnosis of the disease based on the Rotterdam criteria BMI between 18.5 and 35

Exclusion criteria

Exclusion criteria: Taking chemical and herbal medications that affect insulin, sex hormones, or blood lipid levels within the last two months IVF treatment Having diabetes, thyroid disease, hyperprolactinemia, severe liver or kidney disease Pregnancy, breastfeeding, or menopause

Design outcomes

Primary

MeasureTime frame
Fast blood suger. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Fast insulin. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Hemoglobin A1C. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;HOMA-IR index. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: In this study, fasting insulin and fasting glucose levels are collected from blood samples and calculated using the insulin resistance index formula.;Blood cholesterol. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;High-density lipoprotein. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Low-density lipoprotein. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Triglyceride. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Luteinising Hormone. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Follicle-stimulating hormone. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Sex hormone-binding globulin. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Total Testosterone. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Dehydroepiandrosterone. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Dihydrotestosterone. Timepoint: Beginning and end of the study (two months after starting use). Method of measurement: Blood test.;Anti-Mullerian hormone. Timep

Secondary

MeasureTime frame
Waist-to-hip ratio. Timepoint: Beginning and end of the study. Method of measurement: Tape measure at standard points (such as the ends of the shoulders and hips).;Weight. Timepoint: Beginning and end of the study. Method of measurement: Calibrated scale.;Body mass index. Timepoint: Beginning and end of the study. Method of measurement: Calculated based on weight and height.;Hirsutism. Timepoint: Beginning and end of the study. Method of measurement: Using the simplified Freeman-Galloway model, in which only a few key areas (e.g., upper lip, lower abdomen, and thighs) are assessed.;Acne. Timepoint: Beginning and end of the study. Method of measurement: It is assessed using the IGA Score by a trained professional and based on a standard classification.;Menstrual characteristics. Timepoint: Beginning and end of the study. Method of measurement: Participants are assessed through a standard questionnaire about the duration of bleeding and the interval between menstrual periods.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoud zarinkolah

Shiraz University of Medical Sciences

hamedzarinkolah79@gmail.com+98 71 3646 6711

Outcome results

None listed

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