Considering the fact that so far the research in the world has not investigated the effect of Crude oil on the erectile dysfunction.as one of the complications of MS, men have disorder of severity and duration of erection. This will be the first study to determine the effectiveness of crude oil in treatment of erectile dysfuncion in men with multiple sclerosis. Therefore, in this study, we have tried to study the therapeutic properties of this oil, which is completely topical, to improve the erectile dysfunction of MS patients.
Design
The study was performed on 50 patients with MS . The sample is referenced by neurologists
examines the conditions for entry in each case,International index of erectile function questionnaire is complete.
Settings and conduct
The study was performed on 50 patients with MS . The sample is referred by neurologists
, examined the conditions for entry in each case,International index of erectile function questionnaire will be completed. The case and control group will be localy treated with Crude oil and placebo (olive oil) respectivelylocaly for three months.The researcher is blinded to the distribution of the patient to the treatment and control group as well as the patients.
Participants/Inclusion and exclusion criteria
In the leading study, inclusion criteria is men with multiple sclerosis have erectile dysfunction.
Intervention groups
The study was performed on 50 patients with MS. The sample is referenced by neurologists.
examines the conditions for entry in each case,International index of erectile function questionnaire is complete. The experimental group was treated with crude oil for three months under local treatment with placebo (olive oil)on control group.
Main outcome variables
The Effect of Crude Oil on the Treatment of Erectile Dysfunction in Men with Multiple Sclerosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190709044160N1
Registration date:2019-08-17, 1398/05/26
Registration timing:registered_while_recruiting
Last update:2019-08-17, 1398/05/26
Update count:0
Registration date
2019-08-17, 1398/05/26
Registrant information
Name
Abbas Sanjari pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3212 4038
Email address
drsanjari1354@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-23, 1398/03/02
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the Effect of Crude Oil on Erectile Dysfunction in Men with Multiple Sclerosis
Public title
Determination of the Effect of Crude Oil on Erectile Dysfunction in Men with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Man with multiple sclerosis disease and erectile dysfunction
Exclusion criteria:
History of erectile dysfunction before diagnosing multiple sclerosis
History of skin hypersensitivity
Age
No age limit
Gender
Male
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is simple
unit of randomization is individual
tool used in randomization is table of random number
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo without a label and in identical packs by a contributing designer who is not the person completing the questionnaire, is randomly distributed among the participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Shafa Medical and Education Center,Kowsar Blvd, Kerman ,Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Approval date
2019-07-08, 1398/04/17
Ethics committee reference number
IR.KMU.AH.REC.1398.037
Health conditions studied
1
Description of health condition studied
The Effect of Crude Oil on the Treatment of Erectile Dysfunction in Men With Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Percentage of men with multiple sclerosis that suffering erectile dysfunction.
Timepoint
The IIEF questionnaire was completed at the beginning of the study and 3 months after the use of crude oil and placebo.
Method of measurement
IIEF questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Twenty-five men with MS who suffer from impotence and who are interfering with standard cigarette butts in Iran. First, the patient should wash the part of the area with water and soap to be thoroughly cleaned. After washing the skin, slowly massage for 10 minutes, so that the color of the skin reaches red, then drop a few drops of crude oil on the desired parts and begin to massage calmly. Make sure the oil is completely absorbed into the skin, massage at least 5 and not more than 10 minutes, and do it twice a day. At least one hour after that, the crust oil should remain on the skin and not washed.
Category
Treatment - Drugs
2
Description
Control group: Twenty-five men with MS who suffer from impotence and who are interfering with placebo. First, the patient should wash the part of the area with water and soap to be thoroughly cleaned. After washing the skin, slowly massage for 10 minutes, so that the color of the skin reaches red, then drop a few drops of placebo on the desired parts and begin to massage calmly. Make sure the placebo is completely absorbed into the skin, massage at least 5 and not more than 10 minutes, and do it twice a day. At least one hour after that, the placebo should remain on the skin and not washed
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Behnaz Sedighi
Street address
Shafa Medical and Education Center , Kowsar Blvd , Kerman.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drsanjari1354@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman , Kowsar Boulvard , Shafa Medical and Education Center
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drsanjari1354@gmail.com
Grant name
Deputy of Research and Technology of Kerman University of Medical Sciences
Grant code / Reference number
411389339391
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Abbas Sanjaripour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shafa Medical and Education Center , Kowsar Blvd, Kerman.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drsanjari1354@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rostam Seyfaddini
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Shafa Medical and Education Center , Kowsar Blvd, Kerman.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drsanjari1354@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Sanjari Pour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Shafa Medical and Education Center , kowsar Blvd, Kerman.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Email
drsanjari1354@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of international index of erectile function that shares all the data after unidentifiable individuals.
When the data will become available and for how long
After completing the international index of erectile function
To whom data/document is available
Faculty Members of Medical Universities across Iran
What processes are involved for a request to access data/document
The written and formal request of the applicant who has been approved by the research assistant at the university of the applicant's workplace will be sent no later than one week later.