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IRCT20201229049877N1 IRCT 2021-02-06 Tehran University of Medical Sciences Evaluation of Anti hyperglycemic Effect of internal septum of Juglans regia in patients with diabetes mellitus type II: A Double blind Randomized Clinical Trial Primary Evaluation of Anti hyperglycemic Effect of internal septum of Juglans regia in patients with diabetes mellitus type II: A Double blind Randomized Clinical Trial 2021-04-04 anticipated 60 Complete https://irct.ir/trial/53375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization outcome will be done in a block of 4 and through using excel software. This randomization will as follow; at patients arrival to outpatient diabetes clinic, 4 cards (asA, B, C and D) will be introduced and the patient can be chosen only one of them, so then according to the table (four blocks), patient will be divided in group A or B. Patients will be divided into two groups of 30 people, Blinding description: In this study,both of patients and researcher are blinded.Placebo is prepared same as the drug capsule.Drug and placebo are coded into A and B by the third supervisor and randomized by block randomization method. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group: in this group, each patient will receive a capsule containing lyophilized powder of hydroalcoholic extract of internal septum of walnut (J. regia) three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria). Intervention 2: Control group: in this group, each patient will receive a capsule containing pectin as placebo three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Soha Namazi
Pharmaceutical care department,Valiasr hospital,Imam Khomeini Hospital Complex, Tohid Squre
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 namazisoha@yahoo.com Tehran University of Medical Sciences scientific Soha Namazi
Pharmaceutical care department,Valiasr hospital,Imam Khomeini Hospital Complex, Tohid Squre
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6658 1692 namazisoha@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Obtain consent from patients Age between 25 and 70 year old HbA1C≥7% and less than 9% and FPG = 130-250 mg / dl Take metformin and/or other anti-diabetic agents (in maximum and constant dose for three months) or metformin alone (in maximum and constant dose for three months) Constant diet and physical activity during the study (according to a questionnaire translated and validated into Persian) The patient's anti-diabetic medication regimen remained constant during the study No allergies to walnuts 25 years 70 years Both History of walnut allergy Immune system defects Pregnancy and lactation Cardiovascular disease (coronary artery ischemia, EF <45%) Take medications that change blood glucose levels (corticosteroids, tacrolimus, anti-AIDS drugs, antipsychotic drugs) Uncontrolled thyroid disease Acute infection History of diabetic ketoacidosis eGFR<60 ml/min Acute hepatitis (increase in ALT and AST to more than 10 to 20 times normal) cirrhosis Proliferative retinopathy Severe weight loss (at least 10% over 6 months) Consumption of any other medicine and herbal products, including walnuts E11.9 Type 2 diabetes mellitus without complications Treatment - Drugs Placebo Intervention group: in this group, each patient will receive a capsule containing lyophilized powder of hydroalcoholic extract of internal septum of walnut (J. regia) three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria). Control group: in this group, each patient will receive a capsule containing pectin as placebo three times a day before meals for 3 months in addition to other anti-diabetic treatments. At the beginning and end of the study (End of the 12th week), 5 cc of blood samples will be taken from patients to assess blood levels of hemoglobin A1C, fasting blood glucose, insulin, hs CRP, C-peptide AST, ALT,ALP, serum bilirubin and creatinine. The patient's weight, height and waist circumference, hip circumference and blood pressure are also measured. A urine sample is taken from the patient at the beginning and end of the study for urine analysis (for assessing proteinuria). Decreases of hemogllubin A1C (HbA1C)c. Timepoint: 0 and 12 weeks after initiation of the drug. Method of measurement: serum level measurement. Tehran University of Medical Sciences Approved 2020-12-22 Research Ethics Committee of the Research Institute of Pharmaceutical Sciences, Tehran University of Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)