polycystic ovary syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Intervention group: The intervention group consumes 2 capsules daily (together) of a combined supplement of saffron extract and vitamin E, each containing 15 mg of saffron extract and
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Women express their satisfaction by completing a written form to participate in the study. 2- Diagnosis of polycystic ovary syndrome based on the diagnosis of a gynecologist and having PCOS diagnostic criteria according to the guidelines of the American Association for Reproduction (Rotterdam criteria, 2003 which required at least 2 of the following 3 criteria: 1) oligo and/or Absence of ovulation 2) Clinical or biochemical signs of hyperandrogenism and 3) morphology of polycystic ovary shown in ultrasound examination). Women should be between the ages of 18 and 45 People's BMI should be in the range of 25 to 35.
Exclusion criteria
Exclusion criteria: A history of chronic diseases including diabetes, liver disease, cardiovascular and kidney diseases, and endometriosis. Having other disorders that resemble PCOS, including hyperprolactinemia, late-onset congenital adrenal hyperplasia, androgen-secreting tumors, and Cushing's syndrome. Following a special diet and exercise Use of insulin , contraceptives, weight loss agents and anti-inflammatory drugs. Smoking and alcohol consumption in less than 1 month Using any food supplements and antioxidants in the last 1 month Pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Chemiluminescence immunoassay(CLIA).;Dehydroepiandrosterone. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: CLIA.;Hirsutism. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Ferriman–Gallwey index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Malondialdehyde. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: CLIA.;Total Antioxidant Capacity. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: CLIA.;Alopecia. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Sinclair Scale.;Acne. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Global Acne Grading system or GAGS.;Triglyceride. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Photometric.;Total cholesterol. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Photometric.;Low-density cholesterol. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Photometric.;High-density cholesterol. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: Photometric.;Triglyceride Glucose Index. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: • TY-G index: Ln [fasting triglycerides (mg/dL) × fasting plasma glucose (mg/dL)/2].;Total cholesterol-high density lipoprotein ratio. Timepoint: Before the start of the intervention and 8 weeks after taking the supplement of saffron extract and vitamin E. Method of measurement: total cholesterol divided high density lipoprotein.;Fasting blood sugar. Timepoint: Before the start of the intervention and 8 | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Seyedeh Tayebeh Rahideh
Iran University of Medical Sciences
Outcome results
None listed