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IRCT20221117056528N1 IRCT 2022-11-29 Zahedan University of Medical Sciences Evaluation of the effectiveness of Metformin and Curcumin in pcos Evaluation of the effectiveness of Metformin and Curcumin in laboratory criteria in patients with polycystic ovary syndrome 2022-11-26 anticipated 200 Complete https://irct.ir/trial/66956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Block randomization method In order to hide the random allocation process,random 10-digit codes are written on 200 paper labels whitout a specific order and frame,which is the identification number of the relevant and only the project methodologist is aware of the relevent code.The labels will be struck on the medicine packages in the order of the randomization list.When the doctor declares the eligibility of a patient,the methodologist will provide the pakage treatment plan to him.The evaluator is unaware of the type of traetment, Blinding description: Drugs and the placebo will be setting in simillary boxes whitout any name or symptom,and it is provided to the participant by jarh's colleague.The patients and the evaluating researcher are unaware of the type of treatment.In order the analyze the data,a statistician who is not aware of the performed processes will be used. 2-3 Polycystic Ovarian Syndrom. Intervention 1: The first intervention group: 50 patients with polycystic ovary syndrome who were given metformin tablets 500 mg every 8 hours from Dineh Iran for three months. Intervention 2: Intervention group: The second intervention group: 50 patients with polycystic ovary syndrome who were given 80 mg curcumin tablets every 8 hours from Dineh Iran for three months. Intervention 3: Intervention group: The third intervention group: 50 patients with polycystic ovary syndrome who are given 80 mg curcumin tablets every 8 hours and 500 mg metformin tablets from Iran's Dineh company for three months. Intervention 4: Control group: 50 patients with polycystic ovary syndrome who are given a placebo for three months. Yes - There is a plan to make this available What will be shared: It is possible to publish all data anonymously, including laboratory criteria before and after the clinical trial period and changes in body mass and basic criteria such as age and marital status of people. When: 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Use for comparison with other researches in other centers Where to obtain: Dr Fatemeh Feghhi How to obtain: Having permission to do research work from a reputable center Comments:
public Fatemeh Feghhi
Dr. Hasabi Square, Zahedan University of Medical Sciences
Zahedan Iran (Islamic Republic of) 9816743463 054333721514 hfeghhi93@gmail.com Zahedan University of Medical Sciences scientific Fatemeh Feghhi
Dr. Hasabi Square, Zahedan University of Medical Sciences
Zahedan Iran (Islamic Republic of) 9816743463 054333721514 hfeghhi93@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Women with polycystic ovarian syndrom based on the diagnostic criteria of rotterdam including ultrasound examination and symptoms of hyperandrogenism and menstural disorders and ruling out other endocrine disorderssuch as hyperprolactinemia,increase in the thickness of the outer layer of the ovary,cushing syndrom,acromegaly,androgen producing tumors and CAH no limit no limit Female Cardiovascular disease Hepatic disease Renal disease Thyroid disease Sever glucose intolerance User of vitamine and mineral supplementary User of weight reducer drugs IV Endocrine, nutritional and metabolic diseases Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo The first intervention group: 50 patients with polycystic ovary syndrome who were given metformin tablets 500 mg every 8 hours from Dineh Iran for three months. Intervention group: The second intervention group: 50 patients with polycystic ovary syndrome who were given 80 mg curcumin tablets every 8 hours from Dineh Iran for three months. Intervention group: The third intervention group: 50 patients with polycystic ovary syndrome who are given 80 mg curcumin tablets every 8 hours and 500 mg metformin tablets from Iran's Dineh company for three months. Control group: 50 patients with polycystic ovary syndrome who are given a placebo for three months Lipid profile level. Timepoint: First and three months after the study. Method of measurement: with laboratory sampling in mg/dL. Hormone profile levels such as testosterone and luteinizing hormone and Follicle-stimulating Hormone. Timepoint: First and three months after the study. Method of measurement: with laboratory sampling in IU/l. Fasting blood sugar and insulin levels and HOMA-IR. Timepoint: First and three months after the study. Method of measurement: with laboratory sampling in mg/dL. Average anthropometric indices such as waist circumference and hip circumference and body mass index. Timepoint: First and three months after the study. Method of measurement: By measuring weight in kilograms and height in centimeters. Zahedan University of Medical Sciences Approved 2022-10-25 کمیته اخلاق دانشگاه علوم پزشکی زاهدان Dr. Hasabi Square, Zahedan Medical Sciences Campus zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)