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IRCT20190212042686N3 IRCT 2022-12-28 Tabriz University of Medical Sciences The effect of royal jelly supplementation on hormonal status,insulin resistance and inflammatory factors in patients with polycystic ovary syndrome The effect of royal jelly supplementation on hormonal status, insulin resistance and inflammatory factors in patients with polycystic ovary syndrome: pilot study 2022-12-05 anticipated 24 Complete https://irct.ir/trial/67490 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). 2 Polycystic ovary syndrome. Intervention 1: Intervention group: will receive Royal jelly capsule (1000 mg) once a day manufactured by STP pharma factory for 2 months. Intervention 2: Control group: The placebo capsule filled with starch is completely similar to the used supplement and is taken once a day for two months. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Access starting 6 months after publication To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta-analysis. Where to obtain: The researchers (student and her supervisor) How to obtain: 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). Comments:
public dr.Majid Mobasseri
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 8939 Mobasserim@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Dr.Majid Mobasseri
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 8939 mobasserim@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Female volunteers aged 15-45 with clinical symptoms of hyperandrogenism 15 years 45 years Female Pregnancy Breastfeeding Having diseases such as autoimmune diseases Digestive diseases Liver disease Thyroid Unstable cardiovascular diseases Severe respiratory disease (Asthma and Chronic bronchitis) Taking any type of vitamin and mineral supplements in the last six months People with a history of allergies E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: will receive Royal jelly capsule (1000 mg) once a day manufactured by STP pharma factory for 2 months. Control group: The placebo capsule filled with starch is completely similar to the used supplement and is taken once a day for two months. Estrogen. Timepoint: Baseline and 2 months after the treatment. Method of measurement: ELISA Test. Testosterone. Timepoint: Baseline and 2 months after the treatment. Method of measurement: ELISA Test. Sex Hormone-Binding Globulin (SHBG). Timepoint: Baseline and 2 months after the treatment. Method of measurement: ELISA Test. Fasting blood sugar. Timepoint: Baseline and 2 months after the treatment. Method of measurement: Electrochemiluminescence Test. Insulin resistance with HOMA-IR score. Timepoint: Baseline and 2 months after the treatment. Method of measurement: Electrochemiluminescence Test. Interleukin 6. Timepoint: Baseline and 2 months after the treatment. Method of measurement: Electrochemiluminescence Test. Hs-CRP. Timepoint: Baseline and 2 months after the treatment. Method of measurement: Electrochemiluminescence Test. Body mass scale. Timepoint: Baseline and 2 months after the treatment. Method of measurement: Weight scale and stadiometer. Tabriz University of Medical Sciences Approved 2022-12-04 Ethics Committee Tabriz University of Medical Sciences Ethics Committee,Tabriz University of Medical Sciences, Golgasht Street , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)