The effect of royal jelly supplementation on hormonal status, insulin resistance and inflammatory factors in patients with polycystic ovary syndrome: pilot study

Determination of the effect of royal jelly supplementation on hormonal status,insulin resistance and inflammatory factors in patients with (PCOS)

A parallel-group, triple-blind, randomized, phase 2 clinical trial in 24 patients. The rand function of Excel software was used for randomization.

This pilot study will be conducted on 24 women with (PCOS) in Imam Reza Hospital of TBZMED. The patients included in the study will be randomly divided into two groups receiving placebo and intervention receiving 1000 mg of royal jelly per day. The duration of the intervention will be 60 days, and the side effects of the supplement will be recorded by recording all clinical symptoms. Placebo capsules will be prepared and packaged in the form of the supplement. In this study, the researcher, the patient, the laboratory technician and the results analyst will be blinded to the study groups. Before and after the intervention, fasting blood will be taken from all patients and all blood biochemical factors including inflammatory indices, sex hormones, serum insulin and fasting blood sugar will be measured.

Entry criteria: Female volunteers aged 15-45 with clinical symptoms of hyperandrogenism. Exclusion criteria: Lack of consent to participate in the study, Pregnancy, breastfeeding, Suffering from diseases such as Autoimmune, Digestive, Liver, Thyroid and Unstable Cardiovascular diseases, severe respiratory disease, Taking any type of vitamin and mineral supplements in the last six months, people with a history of allergies

Control group: Receive placebo medicine once a day for two months. Intervention group: They receive 100 mg royal jelly tablets daily for two months.

Estrogen, Testosterone, SHBG, FBS, Insulin, Interleukin 6, hs-CRP, BMI

Thanks to the scientific efforts of the officials and colleagues of the center. In this study, the age of the participants was considered to be 18-45 years old. Considering that it is actually necessary to pass 2 years from Menarche to enter the study, there were females who were 15 to 18 years old year and had spent 2 years and so entered the study. Therefore, please change the minimum age from 15 to 18 years.

Stratified permuted block randomization will be applied to stratify participants into different stratum and blocks based on probable confounders including age and BMI. Each block will be randomly allocated to the intervention or control groups. The sequence of the blocks will be prepared for each stratum Random Allocation Software (RAS). For each patient in a definite block, a matched person in terms of the aforementioned variables would be considered in that block. Participants and investigators will be blind to the trial group assignments until the end of the study and data analysis.

Placebo capsules will be prepared and packaged as well as the supplement form. Coding of packages containing supplements and placebos will be done by someone other than the researchers as A, B, and volunteers will be randomly assigned to placebo and intervention groups. In this study, the researcher, the patient, the laboratory technician and the results analyst will be blind to the study groups (triple blind).

Data collected for the primary outcomes will be shared.

Access starting 6 months after publication

The data will only be available for people working in academic institutions.

The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.

The researchers (student and her supervisor)

After the publication of the article, the researchers should have access to the study documents through an email request from the person in charge of the project (mobasserim@tbzmed.ac.ir).