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IRCT20221015056179N1 IRCT 2022-10-17 Ghoum University of Medical Sciences To evaluate the effect of Sweet Almond and Plantago seed, on Proteinuria in patients with Diabetic Nephropathy. To evaluate the effect of a Traditional Persian Medicine product, composed of Sweet Almond and Plantago seed, on Proteinuria in patients with Diabetic Nephropathy. 2022-11-05 anticipated 60 Complete https://irct.ir/trial/66326 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Random allocation of patients to two groups is done using random block allocation method using 4 and 6 blocks. Block sequences are assigned to groups using specified software and patients are assigned to groups based on the determined sequence. N/A Proteinuria in Diabetic Nephropathy. Intervention 1: Intervention group:This group will be given Losartan 25 mg twice a day every 12 hours as well as traditional medicine product (10 grams sachet) twice a day two hours after breakfast and two hours after lunch along with a little water. Intervention 2: Control group: This group will be given Losartan 25 mg twice a day to be given one every 12 hours. (8am/8pm or any other time other than the time of use of traditional medicine products). 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 It is not yet known if there will be a plan to make this available
public Romella Haider
Qom- Zenbilabad Ayatollah Sadoughi Alley 34 No. 5
ghoum Iran (Islamic Republic of) 3716855971 +98 25 3294 3187 rheidar@muq.ac.ir Ghoum University of Medical Sciences scientific Romella Haider
Qom- Zenbilabad Ayatollah Sadoughi Alley 34 No. 5
Ghoum Iran (Islamic Republic of) 3716855971 +98 25 3294 3187 rheidar@muq.ac.ir Ghoum University of Medical Sciences Iran (Islamic Republic of) Informed consent to enter the project People aged 30 to 70 years No kidney failure or any other disease that leads to diabetic nephropathy No symptoms of urinary tract infection during study Not taking anticoagulants, corticosteroids Excretion of albumin between 30-300 mg in 24-hour urine Blood pressure less than 160 mmHg Potassium less than 5.8 mA/L GFR more than 60 ml per minute per 1.73 m3 body Creatinine less than 2 mg/dl No professional athletes Not having Chronic neurological disease (severe depression and anxiety) Non-pregnancy and lactation SGPT rate less than three times normal before study (below 100 units per liter) HbA1C between 7 and 9% No urinary tract infection and kidney ducts. 30 years 70 years Both Causing any complications Dissatisfaction with follow-up treatment Increase proteinuria Drug allergy E13.42 Other specified diabetes mellitus with diabetic polyneuropathy Treatment - Drugs Treatment - Drugs Intervention group:This group will be given Losartan 25 mg twice a day every 12 hours as well as traditional medicine product (10 grams sachet) twice a day two hours after breakfast and two hours after lunch along with a little water. Control group: This group will be given Losartan 25 mg twice a day to be given one every 12 hours. (8am/8pm or any other time other than the time of use of traditional medicine products) Decreased Proteinuria in urine. Timepoint: At the beginning of the study (before the intervention) and on days 30 after the intervention. Method of measurement: UA Urinary Protein. Decreased Proteinuria in 24 hour Urinary protein. Timepoint: At the beginning of the study (before the intervention) and on day 60 after the intervention. Method of measurement: 24 hour Urinary Protein. Ghoum University of Medical Sciences Approved 2022-10-15 Specialized Committee on Ethics in Biomedical Research Safashahr, Jehad Daneshgaahi, Street, Shahid Niasari Alley, No. 85 ghoum Ghoum Iran (Islamic Republic of)