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IRCT20190810044500N4 IRCT 2020-04-25 Yazd University of Medical Sciences Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy Evaluation of therapeutic effects of Crocin in reducing progression of diabetic nephropathy: A randomized triple-blind placebo-controlled trial 2020-04-20 anticipated 44 Complete https://irct.ir/trial/46900 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: the patients will be randomly divided into two groups of intervention and control using the permutation blocks, Blinding description: Blinding will perform on patients, clinical caregivers, including physicians and nurses, as well as variables assessors and data analysts. 2 diabetic nephropathy. Intervention 1: Intervention group: take a 15 mg crocin tablet made by pouyesh darou sina company once daily for 90 days. Intervention 2: Control group: take a placebo tablet made by pouyesh darou sina company once daily for 90 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public behzad kafami
بلوار شهدای گمنام - دانشگاه علوم پزشکی شهید صدوقی
yazd Iran (Islamic Republic of) 8915173143 +98 35 3820 3419 behzadk74@gmail.com Yazd University of Medical Sciences scientific Fatemeh Saghafi
Professor Hesabi Blvd., Yazd Province, Yazd
yazd Iran (Islamic Republic of) ۸۹۱۵۱۷۳۱۴۹ +98 35 3820 3419 F.saghafi@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) age 18 years or older A history of type 2 diabetes for at least 5 years, as defined by the WHO fasting urine albumin/creatinine ratio of 30 mg/g or higher on two separate occasions within the past 3 months HbA1C less than 8 blood pressure less than 160/100 Serum creatinine levels less than or equal to 2 mg/dL treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin treatment of hypercholesterolemia with(but not limited to) a statin 18 years no limit Both GFR less than 30 mL/min/1.73 m2 chronic heartfailure with New York Heart Association class III or IV alcohol dependency or cigarette smoking use of one of certain specified medications within 3 months prior to enrollment in the study (nonsteroidal anti-inflammatory agents and antioxidant supplements, including vitamin E, vitamin C, fish oil extracts [omega-3 fatty acids], green tea preparations, pomegranate extracts, and grape extracts Recent stroke, active cancer, anemia recurrent urinary tract infection pregnancy and lactation Drug intolerance Serious medical conditions in which the patient is unable to attend regular visits include severe cardiovascular disease such as angina or heart attack. Mental conditions that prevent conscious consent to enter the study or follow the study protocol E11.21 Type 2 diabetes mellitus with diabetic nephropathy Treatment - Drugs Placebo Intervention group: take a 15 mg crocin tablet made by pouyesh darou sina company once daily for 90 days. Control group: take a placebo tablet made by pouyesh darou sina company once daily for 90 days. Fasting blood sugar levels. Timepoint: Before and after intervention. Method of measurement: blood sample. Glycosylated hemoglobin. Timepoint: Before and after intervention. Method of measurement: blood sample. , Blood urea nitrogen (BUN). Timepoint: Before and after intervention. Method of measurement: blood sample. Serum creatinine. Timepoint: Before and after intervention. Method of measurement: blood sample. 24-hour urinary protein. Timepoint: Before and after intervention. Method of measurement: blood sample. Urinary albumin-creatinine ratio (UACR),. Timepoint: Before and after intervention. Method of measurement: blood sample. Blood levels of TGF-β. Timepoint: Before and after intervention. Method of measurement: blood sample. Life quality. Timepoint: Before and after intervention. Method of measurement: questionnaire. Adverse effects. Timepoint: Before and after intervention. Method of measurement: questionnaire. Yazd University of Medical Sciences Approved 2019-04-30 faculty of ethics of medical sciences - shahid sadoughi university of medical sciences Gomnam shohada boulevard - shahid sadoughi university of medical sciences yazd Yazd Iran (Islamic Republic of)