Polycystic Ovarian syndrome. Polycystic ovarian syndrome
Conditions
Interventions
Intervention 1: Intervention group: Two melatonin tablet 3 mg (Nature Made, USA), Daily+ a magnesium tablet (each tablet containing 250 mg magnesium in the form of magnesium oxide) (Jalinous, Iran),
Sponsors
Ahvaz University of Medical Sciences
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome based on Rotterdam criteria Age 18-40 years BMI=35 Tendency to participate in the study
Exclusion criteria
Exclusion criteria: Pregnancy Lactation Sleeping disorders The night shift workers ???Any disease that affects metabolic parameters in this trial including Cushing's Syndrome, hypoglycemia, type I or II Diabetes, androgen secreting tumors or congenital adrenal hyperplasia, hyperprolactinemia, hyperparathyroidism, Thyroid disorders, hypertension, Anemia, Allergy, Asthma, Cardiovascular, Kidney, Liver or Pulmonary diseases, Cancer Any drugs that may cause side effects such as menstrual disorders, hirsutism or acne or drugs that affect plasma androgen levels, lipid profile, blood glucose or inflammatory factors during the last 3 months (such as oral contraceptives (OCP), Ovulation induction, anti-androgenic, insulin-sensitizer, blood glucose lowering, anti-obesity, antidepressants, anti-coagulants, Thiazides, Corticosteroids, Metformin, Lipid lowering, NSAIDs, Aspirin) Following the special diet Weight loss of more than 5% body weight in the last 6 months Taking melatonin, magnesium, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment Taking melatonin, magnesium, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment Smoking Alcohol consumption Migration Unwillingness to continue cooperation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of melatonin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum level of magnesium. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry.;Fasting blood sugar. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry.;Insulin. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Insulin resistance. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: insulin resistance formula (HOMA-IR).;Serum triglyceride. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry.;Serum Low Density lipoprotein -Cholesterol (LDL-C). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry.;Serum high Density lipoprotein -Cholesterol (HDL-C ). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry.;Serum total cholesterol. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Spectrophotometry.;Total Testosterone. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Sex hormone-binding globulin (SHBG). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Free androgen index. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: formula.;Total antioxidant capacity (TAC). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Chemical method.;Serum level of Malondialdehyde (MDA). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Thiobarbituric acid method.;Serum level of tumor necrosis factor alpha (TNF-a). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: ELISA kit.;Serum level of High sensitivity C- Reac | — |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index (BMI). Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: BMI Formula.;Waist circumference. Timepoint: At the beginning of the study and 8 weeks later. Method of measurement: Tape. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReihaneh Mousavi
Ahvaz University of Medical Sciences
Outcome results
None listed