]>
IRCT20220224054116N1 IRCT 2022-05-16 Alborz University of Medical Sciences Effect of a traditional medicine "Qurs-e Tabasheer" on diabetes and diabetic nephropathy Effect of Qurs-e Tabasheer, a traditional Persian formula, on blood glucose and renal complications in patients with diabetic nephropathy, a randomized controlled trial 2022-05-07 anticipated 60 Complete https://irct.ir/trial/62212 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Multi-digit codes (barcodes) are written on the packages that only the main person in charge of the research can open the codes if necessary and specify the type of medicine. The codes are arranged in such a way that in the first ten codes, five packages contain one of the drugs and the other five packages contain the second drug. The same proportion is arranged in the second ten codes to the sixth ten codes. (Balanced Block Randomization) This type of design provides the conditions for intermediate tests, So that after the execution of each complete block, statistical tests can be performed, and if the result is reached and the difference between the two groups is significant, and the test power is maintained, the study can be stopped. In this study, random assignment of individuals to the intervention and control groups is performed using the Balanced Block Randomization technique. Due to the fact that the blocks considered in this study are ten blocks, we use Stata software to produce random number chains from 1 to 6 to reach the desired sample size. Preparation of randomly assigned sequences of individuals and their placement in sealed envelopes and numbered with a five-digit serial number is done by a third party who had no role in the design of the study. All envelopes have a random five-digit serial number that opens immediately after completing the basic information and tests and assigns individuals to the intervention or control group, Blinding description: The drug (Qurs-e Tabashir) and placebo (which does not have the active ingredients) are packed in packages containing ten cans. They are both completely similar to each other in terms of size, shape and color. Each box is assigned a code consisting of numbers and letters. These codes are distributed based on a table of random numbers between the drug and placebo groups and the researcher and the patient are not aware of it. In this study, participants, clinical caregivers, researchers, and outcome evaluators are blinded. 3 Diabetes, Diabetic nephropathy. Intervention 1: Intervention group: This group receives Qurs-e Tabasheer (two tablets three times daily) for 12 weeks in addition to their standard treatment. Ingredients of Qurs-e Tabasheer are: Bambusa arundinacea 13.9% , Glycyrrhiza glabra 13.9% , Lactuca sativa 20.9% , Portulaca oleracea 20.9% , Coriandrum sativum 6.99% , Rosa damascena 6.99% , Armenian bole 4.2 درصد% , Acacia senegal2.8% , Punica granatum 2.8% , Santalum album 2.8% , Rhus coriaria 2.8% , Cinnamomum camphora 0.7% . This product is produced in the Pharmaceutics Laboratory of the Faculty of Pharmacy, Alborz University of Medical Sciences. Intervention 2: Control group: This group receives placebo tablet (two tablets three times daily) for 12 weeks in addition to their standard treatment. Placebo is similar to medicine in shape, color and other properties. The substance in the placebo is a harmless food substance (microcrystalline cellulose). No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations, participants' data will be published in general and without mentioning their names and personal information in the research article.
public Mohammad Mahdi Ahmadian-Attari
Faculty of Pharmacy, next to Imam Ali Hospital, Valiasr St, Shura Boulevard
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 ahmadian.attari@gmail.com Alborz University of Medical Sciences scientific Ramin Tajbakhsh
Faculty of Pharmacy, next to Imam Ali Hospital, Valiasr St, Shura Boulevard
Karaj Iran (Islamic Republic of) 3154686689 +98 26 3256 7175 r_tajbakhsh@yahoo.com Alborz University of Medical Sciences Iran (Islamic Republic of) Patients with diabetes and diabetic nephropathy Patients receiving a stable dose of ACEI or ARB eGFR between 15 and 30 (stage 4 CKD) Albuminuria more than 30 mg/day Patients over 18 years old 18 years no limit Both Patients with liver disease, active infection, malignancy Patients with kidney disease from nondiabetic cause Problems with nutrient absorption in gastrointestinal tract Sensitivity to drug components Pregnant or lactating women E11.2 Type 2 diabetes mellitus with kidney complications Treatment - Drugs Placebo Intervention group: This group receives Qurs-e Tabasheer (two tablets three times daily) for 12 weeks in addition to their standard treatment. Ingredients of Qurs-e Tabasheer are: Bambusa arundinacea 13.9% , Glycyrrhiza glabra 13.9% , Lactuca sativa 20.9% , Portulaca oleracea 20.9% , Coriandrum sativum 6.99% , Rosa damascena 6.99% , Armenian bole 4.2 درصد% , Acacia senegal2.8% , Punica granatum 2.8% , Santalum album 2.8% , Rhus coriaria 2.8% , Cinnamomum camphora 0.7% . This product is produced in the Pharmaceutics Laboratory of the Faculty of Pharmacy, Alborz University of Medical Sciences. Control group: This group receives placebo tablet (two tablets three times daily) for 12 weeks in addition to their standard treatment. Placebo is similar to medicine in shape, color and other properties. The substance in the placebo is a harmless food substance (microcrystalline cellulose). Fasting blood sugar. Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Blood test. Serum creatinine. Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Blood test. LDL cholesterol (Low Density Lipoprotein). Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Blood test. Urinary albumin. Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Urine test. Blood urea nitrogen. Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Blood test. Estimated glomerular filtration rate(eGFR). Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Calculating by the formula Cockcroft - Gault. Quality of Life score. Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: Diabetes Quality of Life (DQOL) Questionnaire. Sexual function score. Timepoint: At the beginning of the study and at the end of the 12th week after starting the medication. Method of measurement: FSFI Questionnaire for women and IIEF Questionnaire for men. Alborz University of Medical Sciences Approved 2022-02-01 Research ethics committees of Alborz University of Medical Sciences Office of the Ethics Committee, second floor, Vice chancellor for Research and Technology, Saffarian Alley, Golshahr Blvd, Karaj Karaj Alborz Iran (Islamic Republic of)