The Effect of Topical Product of Saffron (Crocus sativus L.) on Erectile Dysfunction in Men with Diabetes: A Randomized Double Blind Placebo-controlled Trial
Objectives: Assessing the effect of topical Saffron (Crocus sativus L.) product on erectile dysfunction in diabetic men. Design: A double blind (blinding investigators and participants) controlled clinical trial with parallel allocation in two groups of experimental (n=25 patients) and placebo (n=25 patients). Setting and Conduct: Married diabetic males with erectile dysfunction referring to traditional medicine clinic of Mashhad University of Medical Sciences in 1393. Participants Including Major Eligibility Criteria: Inclusion Criterion: Married diabetic men with erectile dysfunction. Exclusion Criteria: A) Patients with psychological disorders and B) Patients with central neurologic disorders. Intervention: A) Experimental Group: Applying 0.5 g of topical Saffron product on penis before intercourse, B) Control Group: Applying 0.5 g of placebo on the penis before intercourse. Major Outcome Measures: Primary outcome measure: Erectile Function, and secondary outcome measures: A) Orgasmic Function, B) Sexual Desire, and C) Intercourse Satisfaction which will be assessed using the Farsi version of the International Index of Erectile Function (IIEF-15) scale before the intervention and 4 weeks after in the experimental and control groups.
General information
Acronym
N/A
IRCT registration information
IRCT registration number:IRCT2014040717169N1
Registration date:2014-06-14, 1393/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Hossein Mohammadzadeh Moghaddam
Name of organization / entity
Traditional Medicine Faculty, Mashhad University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
homm1349@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2014-09-06, 1393/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Topical Product of Saffron (Crocus sativus L.) on Erectile Dysfunction in Men with Diabetes: A Randomized Double Blind Placebo-controlled Trial
Public title
The Effect of Topical Saffron Product on Erectile Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Married diabetic men with erectile dysfunction.
Exclusion Criteria: A) Patients with psychological disorders and B) Patients with central neurologic disorders.
Age
From 20 years old to 80 years old
Gender
Male
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
Randomization method is Simple Randomization using Fleiss table.
Double blinding (blinding investigators and participants) was used to reduce the information bias.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghorayshi Building, Daneshgah Street,
City
Mashhad,
Postal code
91375345
Approval date
2014-02-22, 1392/12/03
Ethics committee reference number
921988
Health conditions studied
1
Description of health condition studied
Erectile Dysfunction
ICD-10 code
N48/4
ICD-10 code description
Impotence of Organic Origin
Primary outcomes
1
Description
Erectile Function
Timepoint
Before Intervention and One Month after Intervention
Method of measurement
Farsi Version of International Index of Erectile Function (IIEF-15)
Secondary outcomes
1
Description
Orgasmic Function
Timepoint
Before Intervention and One Month after Intervention
Method of measurement
Farsi Version of International Index of Erectile Function (IIEF-15)
2
Description
Sexual Desire
Timepoint
Before Intervention and One Month after Intervention
Method of measurement
Farsi Version of International Index of Erectile Function (IIEF-15)
3
Description
Intercourse Satisfaction
Timepoint
Before Intervention and One Month after Intervention
Method of measurement
Farsi Version of International Index of Erectile Function (IIEF-15)
Intervention groups
1
Description
Experimental Group: Rubbing Topical Saffron Product on the Penis before Intercourse
Category
Treatment - Drugs
2
Description
Control Group: Rubbing the Placebo on the Penis before Intercourse.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional Medicine Faculty Clinic, Mashhad University of Medical Sciences
Full name of responsible person
Doctor Seyed Mohammad Nazari
Street address
Next to Sina Hospital, Jahad No. 6 Steet,
City
Mashhad,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
Ghorayshi Building, Daneshgah Street,
City
Mashhad,
Grant name
دکتر سید محمد نظری
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad 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
Traditional Medicine Faculty, Mashhad University of Medical Sciences
Full name of responsible person
Doctor Hossein Mohammadzadeh Moghaddam
Position
PhD Candidate in Traditional Iranian Medicine
Other areas of specialty/work
Street address
Next to Sina Hospital, Jahad No. 6 Street,
City
Mashhad,
Postal code
9135913556
Phone
+98 51 1855 2189
Fax
+98 51 1853 5980
Email
homm1349@gmail.com
Web page address
www.mums.ac.ir/tim
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Ali Shamsa
Position
Professor and Urologist, Renal Transplantation Fellowship,
Other areas of specialty/work
Street address
Imam Reza Hospital,
City
Mashhad,
Postal code
Phone
+98 51 1854 4799
Fax
+98 51 1854 4799
Email
shamsaa@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Traditional Medicine Faculty, Mashhad University of Medical Sciences
Full name of responsible person
Doctor Hossein Mohammadzadeh Moghaddam
Position
PhD Candidate in Traditional Iranian Medicine
Other areas of specialty/work
Street address
Next to Sina Hospital, Jahad No. 6 Street,
City
Mashhad,
Postal code
9135913556
Phone
+98 51 1855 2189
Fax
+98 51 1853 5980
Email
homm1349@gmail.com
Web page address
www.mums.ac.ir/tim
Sharing plan
Deidentified Individual Participant Data Set (IPD)