1. Determining and comparing marital satisfaction before and after drug use in two groups treated with Highsense and placebo
2. Determining and comparing the level of sexual desire from the marital relationship before and after taking the drug in the group treated with Highsense and placebo
3. Determining and comparing the rate of erectile dysfunction before and after taking the drug in the group treated with Highsense and placebo
4. Determining and comparing the rate of orgasm before and after taking the drug in the group treated with Highsense with placebo
Determining and comparing the level of overall satisfaction before and after taking the drug in the group treated with Highsense drug with placebo
Determining and comparing the frequency of side effects after taking the drug in the group treated with Highsense with placebo
Design
Clinical trial with control group, with 2 parallel groups, double-blind, randomized, phase 3 participating with 100 patients.
Settings and conduct
Patients are referred to a researcher by a specialist and enter the trial. Location: Boostan specialized clinic in Kermanshah. Researcher-physician-analyzer-statistician and patients are blinded
Participants/Inclusion and exclusion criteria
suffering erection dysfunction
Intervention groups
Highsense Barij contains ginseng extracts of ginseng and L-arginine versus placebo (placebo)
Main outcome variables
1. Erection rate
2. The satisfaction with the relationship rate
3. The sexual desire rate(Libido)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130722014106N8
Registration date:2020-12-17, 1399/09/27
Registration timing:prospective
Last update:2020-12-17, 1399/09/27
Update count:0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Reza Tahvilian
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6482
Email address
rtahvilian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
2021-02-19, 1399/12/01
Actual recruitment end date
2021-11-22, 1400/09/01
Trial completion date
2022-02-20, 1400/12/01
Scientific title
The effect of highsense barij containinig Tribulus Terrestris extract, Panax ginseng and L-arginine on male libido and comparing with placebo
Randomization is done by block method (Permuted block randomization) so that first all 4 blocks which include two codes A and B are prepared (6 blocks) then random tables of random blocks are selected using placement. These blocks form a sample-sized sequence of codes A and B, each of which is randomly assigned to one of the groups. The list of relevant codes will remain in the formulation section of Barij Essence pharmaceutical Company until the completion of the project. This method will provide both blinding and randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both tablets are available in the same package, size, shape and color, and until decoded, the executors will not know the nature of the drugs.
Also, for statistical analysis, the statistician is unaware of the type of drug and knows two groups called A and B. All the information of the drug code is in the formulation section of Barij Essential Oil Pharmaceutical Company and after the completion of the project, the real names of the groups will be determined
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Approval date
2020-09-12, 1399/06/22
Ethics committee reference number
IR.KUMS.REC.1399.568
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
Score in theIIEF(international index of erection function) questionnaire
Timepoint
Beginning of treatment and end of treatment (6 weeks)
Method of measurement
international index of erection function questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Drug receiving group :500 mg Highsense Barij tablets made by Barij Essence Pharmaceutical Company containing ginseng, Tribulus terrestris extract and L-arginine standardized containing 100 mg of total Saponin extract in each tablet Administer twice a day, one hour after lunch and dinner with a glass of water for 3 months.
Category
Treatment - Drugs
2
Description
Control group: Control group to receive placebo :500 mg non-drug containing tablets made by Barij Essence Pharmaceutical Company and similar to the treatment group, they will take two tablets a Day an hour after lunch and dinner with a glass of water for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah university of medical scienses , faculty of pharmacy
Full name of responsible person
Reza Tahvilian
Street address
Daneshgah Ave. , Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6480
Email
rtahvilian@kums.ac.ir
Web page address
https://pharmacy-school.kums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Khodarahmi
Street address
Shahid Beheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3835 8943
Email
rkhodarahmi@kums.ac.ir
Web page address
Https://kums.ac.ir
Grant name
Reza Khodarahmi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Danedhgah Ave , Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6489
Email
rtahvilian@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah Ave , Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6480
Email
rtahvilian@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Tahvilian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah Ave , Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3427 6480
Email
rtahvilian@kums.ac.ir
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The main consequences are shared after the intervention in the disease
When the data will become available and for how long
One year after publishing the results
To whom data/document is available
Physicians, pharmacists, medicinal professionals and other industrial pharmacy staff.
Under which criteria data/document could be used
Researchers, physicians and medicinal and pharmacy students
From where data/document is obtainable
Contact with executor of the project
What processes are involved for a request to access data/document