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IRCT20200714048106N1 IRCT 2020-07-29 Arak University of Medical Sciences The effect of L-carnitine on erectile dysfunction Evaluation of the effect of adding oral vial L-carnitine on the efficacy of sildenafil citrate tablets in the treatment of erectile dysfunction in men with type 2 diabetes 2021-04-21 anticipated 40 Complete https://irct.ir/trial/49648 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 40 male patients with type 2 diabetes referred to Imam Reza (AS) Diabetes Clinic who complain of erectile dysfunction and this disorder has been approved by a urologist who collaborated with the project, if they have the conditions to enter the study and Using block randomization method and using software are divided into two groups of intervention and control, Blinding description: Blindness, due to its double blindness, is such that in this study, only the specialist in charge of the study is aware of the type of study and the study groups, while patients are not aware of the type of drug used. Also, the intern in charge of the project who is responsible for filling out the questionnaire; He is not aware of the type of groups according to the drug used and only recognizes the groups based on A and B, and the form of demographic information and the International Erectile Dysfunction Questionnaire 5 (IIEF5) are completed for both groups. Patients are randomly divided into intervention and control groups, and both groups receive sildenafil tablets, but the intervention group receives vials of L-carnitine and the placebo control group receives the same vial of L-carnitine, both of which are manufactured by BSK Bio-Fermentation. .receive sildenafil tablets, but the intervention group is vial L-carnitine and the placebo control group is similar to vial L-carnitine, both of which are manufactured by B. They receive bio-fermentation. 3 Erectile dysfunction. Intervention 1: Intervention group: First, the form containing demographic information and the International Erection Questionnaire for patients are completed, and then they receive the sildenafil tablet in addition to the L-carnitine vial manufactured by BSKa Fermentation Company. Sildenafil Citrate 100 mg tablets half an hour before sexual intercourse with oral L-carnitine vial alone or dissolved in 1 g of liquid beverage or food (oral BSK vial of BSK brand made by Iran Bio Fermentation Company) in Consumed during the day. The study will continue for 4 weeks. After 4 weeks, the International Erectile Dysfunction Questionnaire 5 (IIEF5) will be completed again in similar conditions. Intervention 2: Control group: First, the form containing demographic information and the International Erection Questionnaire for patients was completed and patients treated with sildenafil citrate tablets at a dose of 100 mg half an hour before each sexual intercourse with an oral placebo vial with a drink (made by Iran Bio Fermentation Company). Will take. The study will continue for 4 weeks and after 4 weeks, the International Erectile Dysfunction Questionnaire 5 (IIEF5) will be completed again in similar conditions. 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 No more information
public Hesam-o-din Rezae
Payambar-e-azam Complex, Basij Sq., Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 hesameddinrezaei13740624@gmail.com Arak University of Medical Sciences scientific Hesam-o-din Rezae
Payambar-e-azam Complex, Basij Sq., Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 hesameddinrezaei13740624@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Erectile dysfunction Diagnose type 2 diabetes for at least three months No history of taking sildenafil citrate or L-carnitine during the previous three months 40 years 70 years Male Patients with spinal cord injury Patients treated with sildenafil citrate or L-carnitine. Severe kidney failure Known liver disease Erectile dysfunction (ED) with known and treated origin of psychological disorder N52 Male erectile dysfunction Treatment - Drugs Placebo Intervention group: First, the form containing demographic information and the International Erection Questionnaire for patients are completed, and then they receive the sildenafil tablet in addition to the L-carnitine vial manufactured by BSKa Fermentation Company. Sildenafil Citrate 100 mg tablets half an hour before sexual intercourse with oral L-carnitine vial alone or dissolved in 1 g of liquid beverage or food (oral BSK vial of BSK brand made by Iran Bio Fermentation Company) in Consumed during the day. The study will continue for 4 weeks. After 4 weeks, the International Erectile Dysfunction Questionnaire 5 (IIEF5) will be completed again in similar conditions. Control group: First, the form containing demographic information and the International Erection Questionnaire for patients was completed and patients treated with sildenafil citrate tablets at a dose of 100 mg half an hour before each sexual intercourse with an oral placebo vial with a drink (made by Iran Bio Fermentation Company). Will take. The study will continue for 4 weeks and after 4 weeks, the International Erectile Dysfunction Questionnaire 5 (IIEF5) will be completed again in similar conditions. Erectile function. Timepoint: After 4 weeks. Method of measurement: International index of erectile function 5 (IIEF5). Arak University of Medical Sciences Approved 2020-05-10 Ethics committee of Arak University of Medical Sciences Payambar-e-azam Complex, Basij Sq., Sardasht Town Arak Markazi Iran (Islamic Republic of)