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IRCT20220112053700N1 IRCT 2022-02-12 Arak University of Medical Sciences The Effect of L-Arginine Supplementation on Hypogonadism in Patients witht Diabetes Type 2. The Effect of L-Arginine Supplementation on Hypogonadism in Patients witht Diabetes Type 2. 2022-02-12 anticipated 50 Complete https://irct.ir/trial/61262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be Randomly Assigned to Groups A and B by Block Randomization (Quadruple Block). Due to Having Two Intervention and Control Groups, in each Block, There should be an Equal Number of Modes A and B, which According to the Volume of the Four Blocks, there will be Six Different Modes for the Blocks, which are: AABB, ABAB, ABBA BBAA, BABA, BAAB. Different States of the Blocks will be written on Cardboard Cards of the Same Size and Color. According to the Sample Size (50 Patients) and Five Modes of Blocks, 10 Times the Cards were Randomly Selected by Replacing and Selecting the Blocks, Determining the order of Placing Patients in Groups A (Control) and B (Intervention) will do And According to the Sample Size, the Patients with the Inclusion Criteria will be divided in such a way that only the physician treating the patient's diabetes is aware of the division and the researcher (student) and the Patient and the Statistical Expert are not Aware of the Division until the end of the Study, Blinding description: Eligible Patients will be Divided in such a way that only the Physician Treating the Patient's Diabetes is Aware of the Classification and the Researcher (Student) and the Patient and the Statistical Expert are not Aware of the Classification until the end of the Study. 3 Diabetes Type 2. Intervention 1: Intervention group:All Patients Selected from the Intervention Group Should be Treated with Oral L-Arginine Supplement Alone or dissolved in a Beverage or Liquid Food at a rate of 3 Gram per Day (Oral L-Arginine Vial with BSK Brand made by Iran Zist Takhmir Company) The will Continue for 8 Weeks and at the End of each Week the Method of Taking the Drug and Possible Complications and Problems will be Followed up by Phone. Intervention 2: Control group: All Patients in the Control Group will be treated with a Placebo Vial and a Similar Shape and Colore of the Drug at the rate of 3Gram per Day(with BSK Brand made by Iran Zist Takhmir Company) and will be followed Exactly by the Intervention Group by a Student who does not know how to Assign Groups. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the Privacy of the Information, Patient Information is kept Confidential by the Project Manager.
public Bahman Sadehgi
No.31,Mahdie St.,Imam Khomeini St
Arak Iran (Islamic Republic of) 3814955756 +98 86 3222 4476 Reza.naderi1988@yahoo.com Arak University of Medical Sciences scientific Bahman Sadeghi
No.31., Mahdie St., Imam Khomeini St
Arak Iran (Islamic Republic of) 3814955756 +98 86 3222 4476 Reza.naderi1988@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Male Gender Erectile Dysfunction (ED) for at Least 3 Months Having Type 2 Diabetes for at Least a Year Total Testosterone Levels Less than 8 nanomol /Liter or Serum Testosterone in the Range of 8 to 11 nanomol /Liter and Free Testosterone Levels Less than 220 picomoles /Liter Age 40 to 60 Years HBA1C Between 5.5 and 7 (Low and Moderate Risk Diabetes) Do not Take Exogenous Anabolic Steroids 40 years 60 years Male Patients with Erectile Dysfunction (ED) of known Psychological Origin Patients with Prostate Cancer or Benign Prostatic Hyperplasia Patients with a History of Sleep Apnea Patients with Spinal Cord Injury Patients with known and treated Cardiopulmonary Injury Patients with Hyperthyroidism or Hypothyroidism Patients with known Liver Failure Patients with known Renal Failure Patients with a History of Seizures Patients with known Microvascular Complications of Diabetes (Retinopathy, Neuropathy, Nephropathy Taking Anti-Libido Drugs Taking Antipsychotic or Mood Stabilizing or Antidepressant Medications E08 Diabetes mellitus due to underlying condition Treatment - Drugs Treatment - Drugs Intervention group:All Patients Selected from the Intervention Group Should be Treated with Oral L-Arginine Supplement Alone or dissolved in a Beverage or Liquid Food at a rate of 3 Gram per Day (Oral L-Arginine Vial with BSK Brand made by Iran Zist Takhmir Company) The will Continue for 8 Weeks and at the End of each Week the Method of Taking the Drug and Possible Complications and Problems will be Followed up by Phone. Control group: All Patients in the Control Group will be treated with a Placebo Vial and a Similar Shape and Colore of the Drug at the rate of 3Gram per Day(with BSK Brand made by Iran Zist Takhmir Company) and will be followed Exactly by the Intervention Group by a Student who does not know how to Assign Groups. Percentage of Individuals with the International Index of Erectile Function-5 Questionnaire Score of Less than 21. Timepoint: Filling in the Questionnaire at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: The International Index of Erectile Function-5. Free and Total Testosterone Serum Levels. Timepoint: Measurement of Free and Total Testosterone Serum Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: Laboratory Kit by ELISA Method. Fasting Blood Suger. Timepoint: Measurement of Fasting Blood Sugar Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: Laboratory Kit by ELISA Method. Hemoglobin A1C. Timepoint: Measurement of Hemoglobin A1C Levels at the Beginning of the Study and 8 Weeks after Taking L-Arginine Supplement or Placebo. Method of measurement: Laboratory Kit by ELISA Method. Arak University of Medical Sciences Approved 2022-01-16 Ethics Committee of Arak University of Medical Sciences No.31, Mahdie St., Imam Khomeini St Arak Markazi Iran (Islamic Republic of)