study effects of honey –ginger (Zingiber officinale) product on Erectile Dysfunction
Design
in this study, 45 patients who suffer from primary organic impotence will come in this study; each will take two gram of honey –ginger product daily.
Settings and conduct
this study will done in family health clinic, the patients don't know the ingredient of capsules.
Participants/Inclusion and exclusion criteria
Inclusion: patients has an erectile dysfunction.
exclusion: patients who use Warfarin, Heparin OR has a peptic ulcer.
Intervention groups
Prescribing two gram of honey –ginger product daily for two month.
Main outcome variables
The Outcomes will assist two months later with the international index of erectile function Questionnaire (IIEF)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140902019011N3
Registration date:2018-06-29, 1397/04/08
Registration timing:prospective
Last update:2018-06-29, 1397/04/08
Update count:0
Registration date
2018-06-29, 1397/04/08
Registrant information
Name
muhammad attarfar
Name of organization / entity
shaheed Beheshti University of medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
attarfar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-21, 1397/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study effects of honey –ginger (Zingiber officinale) jam on Erectile Dysfunction: a pilot study
Public title
Study effects of honey –ginger (Zingiber officinale) jam on Erectile Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
men’s Suffers from Impotence
Negative Nocturnal penile tumescence
Age > 40 years
Complaint since 3 months at least
Exclusion criteria:
Major surgery in pelvic region
Radiotherapy in pelvic region
History of spinal nerve injury
History of extreme heart failure
History of penis fracture
Peyronie disease
Taking Warfarin, Heparin
History of failed treatment with Sildenafil
Active peptic ulcer
Psychological disorder
Sensitivity to ginger
Hot and Dry Temperament (score above 21 for hotness, above 5 for dryness)
Age
From 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Medical Researchs, Shahid Beheshti University of Medical Sciences
Street address
No.2 SBUMS, Next to Ayatollah Taleghani Hospital, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
198396-3113
Approval date
2015-03-15, 1393/12/24
Ethics committee reference number
SBMU.REC.1393.830
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
IIEF score
Timepoint
before intervention, tow month after intervention
Method of measurement
International Index of Erectile Function (IIEF) Questionnaire
Secondary outcomes
1
Description
BMI
Timepoint
before intervention, tow month after intervention
Method of measurement
scales & meter
2
Description
Body Fat Percentage
Timepoint
before intervention, tow month after intervention
Method of measurement
Omron BF511
3
Description
Visceral Fat Level
Timepoint
before intervention, tow month after intervention
Method of measurement
Omron BF511
4
Description
Skeletal Muscle
Timepoint
before intervention, tow month after intervention
Method of measurement
Omron BF511
Intervention groups
1
Description
1 gram ginger (Zingiber officinale) & 1 gram hony 30 min. after lunch
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Family Health Clinic, Shahid University
Full name of responsible person
Seyed Kazem Foroutan
Street address
Shahed Unversity Family Health Clinic, Next to Mostafa Khomeini Hospital, Palestine squire, Italia ave., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 8898 5918
Email
SKF356@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mokaberinejad
Street address
#8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 6027
Email
rmokaberi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhammad Attarfar
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
#8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
attarfar@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahmood khodadoost
Position
MD, PhD
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
#8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
mkhodadoost@lmo.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Muhammad Attarfar
Position
MD, Ph.D Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
#8, Shams Alley, Across from Shaid Abbaspour St, Vali Asr Ave.
City
Tehran
Province
Tehran
Postal code
14155-6153
Phone
+98 21 8877 3521
Fax
Email
attarfar@sbmu.ac.ir
Web page address
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
demographic and International index of erectile function can be shared.
When the data will become available and for how long
6 month after publish results
To whom data/document is available
available for people working in academic institutions
Under which criteria data/document could be used
the IPD can be shared under Common Creative terms; also the requests should provide abstract and goals of new study
From where data/document is obtainable
contact dr. Mohammad Attarfar.
attarfar@sbmu.ac.ir
What processes are involved for a request to access data/document
the data will sent to any academic researcher who accept CC terms, usually upon 10 days.