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
Determining 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
Design
This study is a double-blind randomized clinical trial with parallel groups that is performed in phase 3 clinical trial on 40 diabetic patients with erectile dysfunction. For randomization in this study, block randomization method with proportional number and software was performed.
Settings and conduct
This study is performed in 40 diabetic patients with erectile dysfunction in Imam Reza Clinic in Arak. Patients are not aware of the type of medication they are taking and For the control group, an oral L-carnitine placebo vial made by the same company was 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. 4 weeks later, patients' erectile function will be evaluated again.
Participants/Inclusion and exclusion criteria
Erectile dysfunction; diagnosis of type 2 diabetes; age 40 to 70 years old; no spinal cord injury
Intervention groups
In the intervention group, sildenafil citrate tablets in the amount of 100 mg half an hour before sexual intercourse with oral vial of carnitine alone or dissolved in a drink or liquid food at a rate of 1 g per day is used and the second group (control group) will also be treated with sildenafil citrate 100 mg half an hour before each sexual intercourse with an oral placebo vial. After 4 weeks, the International Erectile Dysfunction Questionnaire 5 (IIEF5) will be completed again in similar circumstances.
Main outcome variables
Erectile function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200714048106N1
Registration date:2020-07-29, 1399/05/08
Registration timing:prospective
Last update:2020-07-29, 1399/05/08
Update count:0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Hesam-o-din Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 1457 7848
Email address
hesameddinrezaei13740624@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of L-carnitine on erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 40 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.ARAKMU.REC.1399.056
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
N52
ICD-10 code description
Male erectile dysfunction
Primary outcomes
1
Description
Erectile function
Timepoint
After 4 weeks
Method of measurement
International index of erectile function 5 (IIEF5)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clinic
Full name of responsible person
Hesam-o-din Rezaie
Street address
Imam Reza Specialized and Sub-Specialized Clinic, Shahid Shiroudi St.
City
Arak
Province
Markazi
Postal code
3813899589
Phone
+98 86 2402 0021
Email
Imamrezaclinic@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesam-o-din Rezae
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
hesameddinrezaei13740624@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesam-o-din Rezae
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
hesameddinrezaei13740624@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesam-o-din Rezae
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Payambar-e-azam Complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
hesameddinrezaei13740624@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available