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IRCT20121216011763N51 IRCT 2021-03-07 Esfahan University of Medical Sciences The effect of propolis dietary supplement on the status of hs-CRP inflammatory index, sex hormone testosterone levels and metabolic profile of women with polycystic ovary syndrome The effect of propolis dietary supplement consumption on indices of high-sensitivity C-reactive protein, testosterone hormone and metabolic profile in women with polycystic ovary syndrome (PCOS) 2021-10-08 anticipated 56 Complete https://irct.ir/trial/52538 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner. https://www.sealedenvelope.com/simple-randomiser/v1/lists In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age. It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it, Blinding description: For proper blinding, the drug and placebo will be exactly the same in color, size, and odor, and none of the participants and researchers will be aware of them until the end of the study, except for the pharmacist. 3 Polycystic ovarian syndrome. Intervention 1: Intervention group: Daily consumption of two 350 mg tablets containing 250 mg of propolis extract and 100 mg of safe and ineffective combination of microcrystalline cellulose as a supplemental formulation, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks. Intervention 2: Control group: Daily consumption of two 350 mg placebo tablets containing 350 mg of microcrystalline cellulose, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks. Yes - There is a plan to make this available What will be shared: Data can be shared after people are not identified. When: access 1 year after publishing results To whom: Researchers working in academic and scientific institutions Conditions: The data will be available in order to know the details of the research and any secondary analysis of the data is allowed due to the permission of the project owner. Where to obtain: Dr. Gholamreza Askari, Department of Community Nutrition, School of Nutrition, Isfahan University of Medical Sciences, Hezar Jarib St. Askari@mui.ac.ir How to obtain: Submit your application via email to eabbasi97@yahoo.com if your application is approved, you will receive the documents within a maximum of 1 month. Comments:
public Gholamreza Askari
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences scientific Gholamreza Askari
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3171 askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of PCOS according to Rotterdam criterion: According to this criterion, the subjects should have two of the three diagnostic features of PCOS: 1- Oligomenorrhea and anovulation 2- Hyperandrogenism 3- Polycystic ovary Age between 18 and 45 years Not to have sensitivity to bee products Not to take any specific drug more than metformin Not to have laparoscopic ovarian surgery and assisted reproductive technology 18 years 45 years Female Hormone therapy or taking contraceptive pills (OCP) History of gestational hypertension Pregnancy or breastfeeding Menopause Tobacco and alcohol consumption Having following diseases: Diabetes, cardiovascular, hepatic, renal, thyroid, asthma, neoplasm E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: Daily consumption of two 350 mg tablets containing 250 mg of propolis extract and 100 mg of safe and ineffective combination of microcrystalline cellulose as a supplemental formulation, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks Control group: Daily consumption of two 350 mg placebo tablets containing 350 mg of microcrystalline cellulose, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks Homeostatic model assessment of insulin resistance (HOMA-IR). Timepoint: Before study and 12 weeks after supplementation. Method of measurement: formula= (fasting plasma glucose(mmol/l) *fasting insulin (IU/ml))/22.5. Testosterone. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Blood samples by enzymatic method. Triglyceride. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Blood samples by enzymatic method. Cholesterol. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Blood samples by enzymatic method. High density lipoprotein. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Blood samples by enzymatic method. Low density lipoprotein. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Blood samples by enzymatic method. Fasting blood sugar. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Blood samples by enzymatic method. Insulin. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: blood samples by ELISA kits. Highly sensitive C-reactive protein. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: blood samples by ELISA kits. Blood pressure. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: barometer. Weight. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Digital scales. Waist. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Inelastic meters. Hip. Timepoint: Before study and 12 weeks after supplementation. Method of measurement: Inelastic meters. Esfahan University of Medical Sciences Approved 2020-11-25 Ethics Committee of Isfahan University of Medical Sciences Hezar Jarib St., Isfahan University of Medical Sciences, School of Nutrition, Department of Community Nutrition, Dr. Gholamreza Askari Isfahan Isfehan Iran (Islamic Republic of)