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IRCT20110614006804N3 IRCT 2024-01-23 Bagheiat-allah University of Medical Sciences The effects of Piacidin in treatment of diabetes The investigation of the therapeutic effects of Piacidin capsule in patients with type 2 diabetes mellitus: a double-blind study 2024-02-20 anticipated 66 Complete https://irct.ir/trial/75029 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, piacidin and placebo capsules will be prepared in the same packaging and appearance and size. Then, they are coded based on the codes already prepared using random numbers table. Randomization method: Permuted block randomization is done so that first all blocks of size 4 containing two codes A and B are prepared and then random blocks are selected by placement using random numbers table (17 blocks). Each of codes is randomly assigned to one of the groups. The list of codes for each drug will remain with one of the executors until the end of the study. Numerical codes from 1 to 66 are recorded on drugs, and patients receive drug no. 1 to 66 after entering the study, respectively, Blinding description: In the present study, patients will be divided into treatment and placebo groups. The treatment group will receive piacidin capsule. The placebo group will receive placebo capsule; which is similar in color, shape and size to the piacidin capsule. First, we explain to the patients that they will receive one of the two treatments, piacidin or placebo, randomly. Patients are put in group A or B. According to this, one of the drugs that are completely identical in appearance and only tagged as A, B will be prescribed for him/her. Participants (diabetic patients) and Outcome assessor will be blinded. 3 type 2 diabetes mellitus. Intervention group: Includes diabetic patients who receive piacidin capsules (300 mg).. Yes - There is a plan to make this available What will be shared: All data is shareable after de-identifying individuals. When: After publication of article To whom: For academic and scientific researchers and institutions Conditions: After researcher's request assessment, it could be possible for sharing the data. Where to obtain: Via the corresponding author of the research. How to obtain: First of all a requesting email should send for the corresponding author;after the confirmation of the sender identity and his/her goal, we could share the data. Comments:
public Mohammad Javad Behzadnia
Emergency department, Baghyatallah Hospital, Nosrati alley, Sheikh Bahaie street, Molla Sadra street, Vanaq square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 2012 behzadnia@bmsu.ac.ir Bagheiat-allah University of Medical Sciences scientific Mohammad Javad Behzadnia
Emergency department, Baghyatallah Hospital, Nosrati alley, Sheikh Bahaie street, Molla Sadra street, Vanaq square
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8126 2012 behzadnia@bmsu.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) 1- Blood triglyceride level should be between 150 and 500 mg/dL. 2- HbA1c level should be less than 8.5%. 3- The age of patients should be between 30 and 65 years. 4- Patients should not make any changes in their blood sugar lowering drug regimen or their physical activity.5- Patients should not have systemic diseases or malignancy or chronic kidney or liver diseases. 30 years 65 years Both Type 2 dia E11 Treatment - Drugs Intervention group: Includes diabetic patients who receive piacidin capsules (300 mg). Quantitative measurement of serum nitric Oxide, glutathione and malondialdehyde levels, blood sugar and lipid levels. Timepoint: before drug administration (day 0) and 3 month after drug administration (day 90). Method of measurement: Oxidative stress and nitric oxide serum levels will be measured using specific biochemical kits, blood sugar and lipids variables will be assessed based on individual laboratory sample results. None applicable. Timepoint: none applicable. Method of measurement: none applicable. Bagheiat-allah University of Medical Sciences Approved 2023-12-11 Baqiyatallah hospital Trauma Research Center; Baqiyatallah University of Medical Sciences; Nosrati alley; Sheikh Bahaie street; Molla Sadra street; Vanaq square Tehran Tehran Iran (Islamic Republic of)