Polycyctic ovary syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women 18-40 years old Having polycystic ovary syndrome according to the Rotterdam criteria and diagnosed by an obstetrician and gynecologis Oligomenorrhea (at least two months) Body mass index (BMI) = 35
Exclusion criteria
Exclusion criteria: The presence of other causes of oligomenorrhea including hyperprolactinemia, hyper/hypothyroidism, congenital adrenal hyperplasia, structural or malignant disorders, etc. according to the opinion of the obstetrician and gynecologist The presence of uncontrolled cardiovascular, hepatic, renal, endocrine and metabolic diseases Use of anticoagulant drugs Use of hormonal drugs (oral contraceptives) Use of other medicinal herbs effective in menstrual disorders History of allergy to herbal medicines including thyme and jujube Being pregnant Intention to become pregnant Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual status (Menstrual timing and pattern). Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: Assessed based on patient self-report.;Average body mass index. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: using a scale and measuring tape. Patients were weighed with minimal clothing and no shoes, using a scale with a precision of 0.5 kg. Height was measured without shoes using a wall-mounted measuring tape with a precision of 1 cm. BMI was calculated by dividing weight (kg) by the square of height (m²).;Number of follicles and ovarian volume in uterine and ovarian ultrasound. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: Ultrasound assessment of the uterus and ovaries was performed by a gynecologist during the menstrual period (days 3–5) at the beginning and end of the study. The ovaries were evaluated for the number of follicles (more than 12 follicles with a size of 2–9 mm is diagnostic for PCOS) and ovarian volume (an ovarian volume greater than 10 mL indicates PCOS).;Quality of life index. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: The effect of treatment on the quality of life in patients with PCOS was assessed using the Polycystic Ovary Syndrome Questionnaire.;Insulin indices. Timepoint: On day 1 and after 90 daysafter drug administration. Method of measurement: Laboratory examination including fasting insulin and insulin resistance.;Drug-related adverse events. Timepoint: On day 1 and after 90 days after drug administration. Method of measurement: The Common Terminology Criteria for Adverse Events (a tool that defines and grades the severity of adverse events resulting from drug therapy or other medical interventions. It categorizes these events on a scale from 1 to 5 (mild, moderate, severe, life-threatening, and death)). | — |
Countries
Iran (Islamic Republic of)
Contacts
Iran University of Medical Sciences