Polycystic Ovary Syndrome (PCOS)
Conditions
Interventions
Metformin group:Metformin 500 milligrams orally once daily for 12 weeks
Herbal capsule group:Standardized herbal capsule 500 milligrams orally once daily for 12 weeks (equal parts Foeniculum vulgare, Vitex agnus-castus, and Daucus carota)
Combination therapy group:Metformin 500 milligrams plus standardized herbal capsule 500 milligrams orally once daily for 12 weeks
Sponsors
Vice-Chancellor in Research Affairs, Shahid Beheshti University of Medical Sciences (SBMU)
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Eligible participants were women aged 18–45 years who met the Rotterdam diagnostic criteria for polycystic ovary syndrome, had oligomenorrhea defined as a menstrual interval >35 days, were non-smokers, provided written informed consent, and had not used PCOS-related medications within the previous 6 months. Participants were required to have no pregnancy, no abortion or postpartum status within the prior 6 weeks, no breastfeeding, and no use of hormonal drugs within the previous month. To avoid secondary causes of hyperandrogenism or hyperinsulinemia, women with diabetes mellitus, Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia, or thyroid dysfunction were not eligible; women with blood pressure disease and those with a family history of breast or ovarian cancer were also excluded at screening.
Exclusion criteria
Exclusion criteria: Participants were excluded if they were unwilling to continue or did not adhere to the protocol, had apparent diabetes or diagnosed hypo/hyperthyroidism on pre-study testing, used oral contraceptive pills or other hormonal therapies during the study period, required ovulation induction/egg stimulation or infertility interventions, had hyperprolactinemia, required other medical interventions or surgery, became pregnant during follow-up, or developed severe adverse drug reactions classified as CTCAE grade 3–5 during the 12-week intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual cycle interval;Serum luteinizing hormone concentration;Fasting serum insulin concentration;Insulin resistance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total cholesterol concentration;High-density lipoprotein cholesterol concentration;Low-density lipoprotein cholesterol concentration;Triglyceride concentration;Right ovary dimension;Left ovary dimension;Right ovarian artery resistance index;Left ovarian artery resistance index;Hirsutism score;Acne severity;Menstrual bleeding duration ;Menstrual bleeding volume; | — |
Countries
Iran
Contacts
Public ContactMojgan Tansaz
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Outcome results
None listed