Evaluation of the Effect of Propolis Supplement on Metabolic, Hormonal, Inflammatory, Clinical and Metabolic Indices in Women with Polycystic Ovary Syndrome

Determining the effect of Propolis supplement on metabolic, hormonal, inflammatory, clinical, and basal metabolic rate in women with Polycystic ovary syndrome

Two arms parallel-group randomized trial with control group, double-blind, phase 2 on 70 patients, randomization software (RAS) was used for randomization.

70 women with Polycystic ovary syndrome referred to Motazedi Medical Center are diagnosed and selected by gynecologists and endocrinologists if there are at least two factors based on Rotterdam criteria. Individuals will be randomly divided into two groups: placebo and intervention. Researchers and participants were blinded by the study group. For this purpose, the codes assigned to each participant are grouped by a third party (unaware of the study)

Inclusion criteria: Female, Aged 18-45 years, Having Polycystic ovary syndrome according to Rotterdam criteria, Body mass index (BMI) greater than or equal to 18.5 kg/m2; Exclusion criteria: 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 a 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

Patients in the intervention group will take 300 mg of Propolis supplement three times per day, one hour after each meal with a glass of water. Patients in the placebo group will take three placebo tablets daily with the same shape, color, and size similar to the Propolis supplement. The duration of the intervention will be 12 weeks.

High-sensitivity C-reactive Protein; Insulin Resistance Index; Free androgen index

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.

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.

All data related to the primary and secondary outcome will be shared

Access starts 6 months after the results are published

Researchers in academic and scientific institutions, as well as people in the industry, are allowed to access the data

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.

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

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.