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IRCT20200912048693N1 IRCT 2020-09-17 Kermanshah University of Medical Sciences Evaluation of the Effect of Propolis Supplement on Women with Polycystic Ovary Syndrome Evaluation of the Effect of Propolis Supplement on Metabolic, Hormonal, Inflammatory, Clinical and Metabolic Indices in Women with Polycystic Ovary Syndrome 2020-11-20 anticipated 70 Complete https://irct.ir/trial/50883 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Due to simple randomization, each person participating in the study is assigned a random code created by random allocation software (RAS) and these codes are divided into two groups by a third person who is unaware of the study and its conditions, Blinding description: Participants in this study do not know whether they are in the intervention or control group, Researchers do not know which participant is in the intervention or control group. In order to blindness, each participant in the study is assigned a random code created by random allocation software (RAS), and these codes are divided into two groups by a third person who is unaware of the study and its conditions. 2-3 Polycystic Ovary Syndrome. Intervention 1: Intervention group: Consumption material: Propolis; Chemical composition and concentration: Different types of Flavonoids, Cinnamic acid derivatives, 50% plant gum or resin, 30% wax, 10% essential fatty acids, 5% pollen, and 5% organic compounds, vitamins and minerals; Dosage: 300 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally; Manufacturer: Shahdineh Golha Company. Intervention 2: Control group: Consumption material: Avicel; Chemical composition: Cellulose microcrystalline; Dosage: 300 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally; Manufacturer: Pishgaman Shimi. Yes - There is a plan to make this available What will be shared: All data related to the primary and secondary outcome will be shared When: Access starts 6 months after the results are published To whom: Researchers in academic and scientific institutions, as well as people in the industry, are allowed to access the data Conditions: Anyone who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All of these steps will not take more than 10 days. Where to obtain: Amir Saber, Assistant Professor, Kermanshah University of Medical Sciences, Faculty of Nutrition Sciences and Food Industry, Address: Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah Postal code: 6719851552 Phone: 0098 83 37102009 Email: amir.saber@kums.ac.ir How to obtain: After sending the request by the applicant and confirming the goals and method of the study by all project researchers, the data will be provided by email in less than 10 days. Comments:
public Amir Saber
Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2009 amir.saber@kums.ac.ir Kermanshah University of Medical Sciences scientific Amir Saber
Faculty of Nutrition Sciences and Food Industry, Next to Farabi hospital, Esar Square, Kermanshah
Kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2009 amir.saber@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Having Polycystic ovary syndrome according to Rotterdam criteria Body mass index (BMI) greater than or equal to 18.5 kg/m2 18 years 45 years Female Pregnancy Lactation Insulin injection People with autoimmune diseases People with gastrointestinal diseases People with liver disease People with thyroid disease People with cardiovascular disease People with severe respiratory illness such as asthma and chronic bronchitis Consume any vitamins, minerals and dietary supplements Existence of allergies to Propolis, Honey and bee products E28.2 Polycystic ovarian syndrome Rehabilitation Placebo Intervention group: Consumption material: Propolis; Chemical composition and concentration: Different types of Flavonoids, Cinnamic acid derivatives, 50% plant gum or resin, 30% wax, 10% essential fatty acids, 5% pollen, and 5% organic compounds, vitamins and minerals; Dosage: 300 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally; Manufacturer: Shahdineh Golha Company Control group: Consumption material: Avicel; Chemical composition: Cellulose microcrystalline; Dosage: 300 mg per day; Daily usage: 3 times a day; Duration of use: 12 weeks; How to use: orally; Manufacturer: Pishgaman Shimi High-sensitivity C-reactive Protein. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Insulin Resistance Index. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: HOMA-IR={[Fasting insulin (microunits/ml)] × [Fasting Glucose (mmol/l)]}/22.5. Free androgen index. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Free androgen index = 100 X [(Total Testosterone)/Sex hormone binding globulin]. Body mass index. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Body mass index=body mass (kg)/ the square of the body height (m). Omentin-1. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Chemerin. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Neopterin. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Testosterone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Follicle-stimulating hormone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Luteinizing hormone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Dehydroepiandrosterone. Timepoint: At the beginning of the study (before the intervention) and at the end of the study. Method of measurement: Enzyme-Linked Immunosorbent Assay. Vice Chancellor for Research, Kermanshah University of Medical Sciences Approved 2020-09-12 Ethics committee of Kermanshah University of Medical Sciences Faculty of Nutrition Sciences and Food Industry, next to Farabi hospital, Esar square, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)