The aim of this double-blind, randomized, clinical trial study, is to assess the effect of Stimol (Citrulline Malate) on Sexual Dysfunction in Multiple Sclerosis patients. In this study, 50 patients with multiple sclerosis, who suffering from sexual dysfunction refer to the Zanjan neurology clinic are recruited.Patients will rule out for anatomical sexual dysfunction. also patients with Pregnancy and breast feeding will be excluded. For all patients sexual dysfunction standard questionnaire will be completed. Then they are randomly assigned to two 25-member groups.The first group will take 1gram citrulline malate oral solution 3 times a day for 30 days, and the second group will take placebo. After 30 days, for all the participants the questionnaires will be completed again and results will analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090629725N1
Registration date:2017-04-11, 1396/01/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-11, 1396/01/22
Registrant information
Name
Negar Farhoodi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4000
Email address
penefadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
research center of zanjan university of medical science
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-07-28, 1396/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study Of Subjective Effect Of Stimol (Citrulline Malate) On Sexual Dysfunction In Multiple Sclerosis Patients
Public title
Study Of Subjective Effect Of Stimol (Citrulline Malate) On Sexual Dysfunction In Multiple Sclerosis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Patients with multiple sclerosis who have sexual dysfunction; Not using stimol currently.
exclusion criteria: Anatomical sexual dysfunction; Use libido booster drugs; Pregnancy and breast feeding.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
For elimination of the possibility of any probable bias due to the knowledge of patients and assessing physicians about the type of treatment we will perform a double blind study. Stimol and placebo will be pack and for this reason patients and assessing physicians do not have any knowledge about the type of treatment. Randomization will be performed by the Randlist software and every patient will be entered in the treatment or placebo groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Postal code
4515613191
Approval date
2016-04-21, 1395/02/02
Ethics committee reference number
ZUMS.REC.1395.28
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
F52.9
ICD-10 code description
Unspecified Sexual Dysfunction, not Caused by Organic Disorder or Disease
Primary outcomes
1
Description
sexual dysfunction in MS patients
Timepoint
First Day and One Month Later
Method of measurement
IIEF-5 Standard Questionnaire for Men and FSFI Standard Questionnaire for women
Secondary outcomes
empty
Intervention groups
1
Description
25 Patients: Oral Solution Stimol 3 gr per Day For 30 Days
Category
Treatment - Drugs
2
Description
25 Patients: Placebo For 30 Days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic Of Valiasr Hospital
Full name of responsible person
Dr. Negar Farhoodi
Street address
Valiasr Hospital, Valiasr Sq, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Shoghli
Street address
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Koorosh Kamali
Position
Assisstant Professor of Epidemiology
Other areas of specialty/work
Street address
Medical Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Postal code
45157-77978
Phone
+98 24 3378 1300
Fax
Email
drkamali@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Ghoreishi
Position
Associate Professor Of Neurology
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Sq, Zanjan
City
Zanjan
Postal code
4513615788
Phone
+243 37 70805
Fax
Email
ar.ghoreishy@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Negar Farhoodi
Position
Neurology Resident
Other areas of specialty/work
Street address
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Postal code
4513615788
Phone
+98 33770805
Fax
Email
penefadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)