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IRCT20221205056719N1 IRCT 2023-01-15 Ahvaz University of Medical Sciences Ginger in PCOS The effects of ginger powder supplementation on biochemical, hormonal, and inflammatory factors, and serum oxidative stress in women with polycystic ovary syndrome 2023-01-10 anticipated 48 Complete https://irct.ir/trial/67247 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the inclusion and exclusion criteria, people are randomly divided into 2 intervention groups and control groups by assigning three-digit codes by random assignment software (RAS). Allocation concealment will be used for concealment. This work is done using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes). In this method, each of the random sequences created is recorded on a card and the cards will be placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelopes is glued and they are placed in a box. At the time of the registration of the participants, based on the order of entry of the eligible participants to the study, the envelopes will be opened in order and the assigned group of that participant will be revealed, Blinding description: Ginger capsules and placebo are distributed in containers that are identical in appearance and coded by a person other than the investigator. None of the participants and the investigator will know about the group in which the people are located, and the coding will be done by someone other than the researcher. Necessary explanations are provided for eligible people to participate in the research and informed consent is obtained from them. N/A polycystic ovary syndrome. Intervention 1: Intervention group: Ginger, 500 mg, 4 doses daily, for 12 weeks. Intervention 2: Control group: Placebo, 500mg, 4 doses daily, for 12 weeks. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable participant When: 12 months after publication To whom: people working in academic institutions Conditions: Confidential raw data for secondary analysis will be available to researchers. Where to obtain: Zeinab Heidari zeynab.heydari67@gmail.com How to obtain: Submit a proposal from prestigious academic institution Comments:
public Zeinab Heidari
Golestan highway
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3311 2930 Zeynab.heydari67@gmail.com Ahvaz University of Medical Sciences scientific Dr. Majid Mohammadshahi
Golestan highway
Ahvaz Iran (Islamic Republic of) 61357-15794 0099 6133115441 shahi334@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age above 18 years BMI above 18.5 Diagnosis and confirmation of polycystic ovary syndrome by an endocrinologist and metabolism specialist based on the Rotterdam criteria Willingness to cooperate 18 years no limit Female Unwillingness to participate in the study Pregnancy Lactation Menopause Having other causes of hyperandrogenism such as congenital adrenal hyperplasia, Cushing's syndrome, ovarian or adrenal tumor Having any type of disease that affects hormonal parameters, such as hypoglycemia, diabetes, hyperprolactinemia, hyperparathyroidism, thyroid disorders, hypertension, anemia, allergies, asthma, cardiovascular, kidney, liver, lung, and cancer. Taking ginger supplements in the last three months Anticoagulant, diabetes and blood pressure medications (due to interference with ginger) during the study Following special diets E28.2 Polycystic ovarian syndrome Treatment - Drugs Placebo Intervention group: Ginger, 500 mg, 4 doses daily, for 12 weeks Control group: Placebo, 500mg, 4 doses daily, for 12 weeks Fasting blood sugar. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Glycosylated hemoglobin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Serum insulin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Triglycerides. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Total cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. High density lipoprotein cholesterol. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method. Interleukin 6. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Total antioxidant capacity. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Malondialdehyde. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Anti mullerian hormone. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Leptin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Testosterone. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Sex hormone binding globulin. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: ELISA Kit. Insulin resistance. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: HOMA-IR. Insulin sensitivity. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: QUICKI. Ahvaz University of Medical Sciences Approved 2022-12-04 Ethics committee of Ahvaz Jundishapour University of Medical Sciences Golestan highway, Jundishapour university of medical sciences Ahvaz Khouzestan Iran (Islamic Republic of)