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IRCT20200922048802N2 IRCT 2020-12-22 Yazd University of Medical Sciences Determination of the effect of licorice on Sex hormone, insulin and fasting blood sugar, blood lipids, depression, sleep quality and appetite in participants with polycystic ovary syndrome (PCOS) and overweight / obesity. Determination of the effect of licorice extract on testosterone and Sex hormone binding globulin (SHBG), LH, FSH, Insulin, FBS, LDL, HDL, TG, Cholesterol, sleep quality, depression, and appetite in participants with polycystic ovary syndrome (PCOS) and overweight / obesity. 2020-09-22 anticipated 72 Complete https://irct.ir/trial/51912 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Simple Random unit: Individual Tool: Randomized Tables A balanced block method is used to allocate concealment so that the number of samples assigned to each of the groups is equal, Blinding description: Supplements of licorice and placebo in the same capsules in terms of size, color and shape Encodes A and B on supplements and placebo. 3 Condition 1: Polycystic ovarian syndrome. Condition 2: Overweight and obesity. Intervention 1: People in this group will recieve three 500 mg capsules of licorice daily for 8 weeks. Intervention 2: Control group: People in this group will recieve three 500 mg capsules of placebo daily for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hadis Hooshmandi
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 hadis.july.1994@gmail.com Yazd University of Medical Sciences scientific Azadeh Nadjarzadeh
School of health, Shahid Sadoughi university of medical sciences, Shohadaye Gomnam Blvd., Alam Sq,
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 azadehnajarzadeh@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18 to 45 BMI 25-35 kg/m2 Polycystic ovary syndrome based on Rotterdam criteria 18 years 45 years Female Blood pressure equal or than 90/140 mmHg Cardiovascular diseases with regular drug use, liver, kidney and thyroid disorders, diabetes Taking multi vitamin-mineral supplements Smoking Antioxidant and herbal treatments during the last 3 months Pregnancy and lactation Consumption of licorice more than 300 grams per week Hyper androgenism includes hereditary adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and hypothyroidism or androgen-secreting tumors History of allergy to licorice or any of its components E28.2 E66 Polycystic ovarian syndrome Overweight and obesity Treatment - Drugs Treatment - Drugs People in this group will recieve three 500 mg capsules of licorice daily for 8 weeks. Control group: People in this group will recieve three 500 mg capsules of placebo daily for 8 weeks. Serum testosterone level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: ELISA Kit. Serum SHBG level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: ELISA Kit. Serum FSH level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: ELISA Kit. Serum LH level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: ELISA Kit. Serum insulin level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: ELISA Kit. Serum FBS level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Biochemical analysis. Serum LDL level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Biochemical analysis. Serum HDL level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Biochemical analysis. Serum TG level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Biochemical analysis. Serum Cholesterol level. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Biochemical analysis. BDI questionnaire. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Likert scale. Pittsburgh Sleep Quality Index (PSQI). Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Likert scale. The Council on Nutrition Appetite Questionnaire (CNAQ). Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Likert scale. Body composition. Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Body analyzer. Anthropometric measurements (height, weight, BMI, waist circumference, hip circumference, abdominal / hip ratio). Timepoint: at the beginning and end of 8-weeks intervention period. Method of measurement: Body analyzer. Yazd University of Medical Sciences Approved 2019-02-18 Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd School of health, Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd., Alem Sq. Yazd Yazd Iran (Islamic Republic of)