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Comparison of the Effectiveness of Herbal Tablet containing Ginkgo biloba,- Hypericum perforatum - Epimedium pinnatum - Citrus aurantifulia and Panax ginseng extracts versus Clomipramine and Placebo in the Treatment of Premature Ejaculation

Protocol summary

Study aim
Comparison of the Effectiveness of Herbal Tablet containing Ginkgo biloba,- Hypericum perforatum - Epimedium pinnatum - Citrus aurantifulia and Panax ginseng extracts versus Clomipramine and Placebo in the Treatment of Premature Ejaculation
Design
The total sample size is 150 individuals that are randomly divided into three groups of 50 herbal group, placebo and Clomipramine. The study is done in a three-blinded manner. Patients in the herbal group, two in the Clomipramine group, one in 25 mg tablets, and in the placebo group, consumed one 100 mg starch tablet one to two hours before each intercourse for 2 months and ejaculated before and after After treatment
Settings and conduct
Mostafaviyan Specialized clinic
Participants/Inclusion and exclusion criteria
‏Inclusion ceriteria: Married men aged 18 to 55 years, Ejaculation duration less than 100 seconds, Men who have been married for at least six months, Getting a score above 8 on the PEDT (Premature Ejaculation diagnostic tool) questionnaire. ‏Inclusion ceriteria: Use of other medicines for premature ejaculation, Alcohol Consumers. Opiods Consumers, Premature ejaculation due to organ failure, Antidepressant drug's Consumers, History of mental's illness, Having severe illnesses (Diabetes Mellitus, Kidney disease and Heart disease)
Intervention groups
The study included three groups of herbal tablet's, Placebo and Clomipramine. One to two hours before intercourse, patients in the herbal group take 2 tablets containing the herbal extracts, patients in the Clomipramine group, One 25mg tablet, and the patients in the placebo group take one 100 mg tablet of starch.
Main outcome variables
Ejaculation time after each intercourse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130911014630N7
Registration date: 2019-09-01, 1398/06/10
Registration timing: registered_while_recruiting

Last update: 2019-09-01, 1398/06/10
Update count: 0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Mohammad Azadbakht
Name of organization / entity
Mazandaran University of Medical Scinecee
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3728
Email address
mazadbakht@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-21, 1398/05/30
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Herbal Tablet containing Ginkgo biloba,- Hypericum perforatum - Epimedium pinnatum - Citrus aurantifulia and Panax ginseng extracts versus Clomipramine and Placebo in the Treatment of Premature Ejaculation
Public title
Comparison of the Effectiveness of Herbal Tablet containing Ginkgo biloba,- Hypericum perforatum - Epimedium pinnatum - Citrus aurantifulia and Panax ginseng extracts versus Clomipramine and Placebo in the Treatment of Premature Ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married men aged 18 to 55 years Ejaculation duration less than 100 seconds Men who have been married for at least six months Getting a score above 8 on the PEDT (Premature Ejaculation diagnostic tool ) questionnaire Premature ejaculation due to organ failure
Exclusion criteria:
Use of other medicines for premature ejaculation Alcohol Consumers Opiods Consumers Antidepressant drug's Consumers History of mental's illness Having severe illnesses (Diabetes Mellitus, Kidney disease and Heart disease)
Age
From 18 years old to 55 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, using random numbers table
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, urologists, patients and researchers have no information about herbal tablet or placebo or Clomipramine , and the product has predetermined codes and is randomly given to patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Farah abad street
City
Sari
Province
Mazandaran
Postal code
4847191971
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.MAZUMS.RIB.REC.1398.035

Health conditions studied

1

Description of health condition studied
انزال زودرس
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation

Primary outcomes

1

Description
Ejaculation Time
Timepoint
After every intercourse
Method of measurement
By the timer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group I: 325 mg herbal tablets, containing 200 mg Epimedium pinnatum , 50 mg Ginkgo biloba, 40 mg Hypericum perforatum, 20 mg Panax ginseng and 15 mg Citrus aurantifulia. Men take 2 herbal tablet, one to two hours before each intercourse for 2 months and report the time of ejaculation before and after treatment.
Category
Treatment - Drugs

2

Description
Intervention group II: : Clomipramine group in which patients take a 25 mg tablet one to two hours before each intercourse for 2 months and report ejaculation time before and after treatment.
Category
Treatment - Drugs

3

Description
Intervention group III: Placebo group in which patients take a 100 mg tablet, containing starch one to two hours before each intercourse for 2 months and report ejaculation time before and after treatment.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Moustafavian Specialty Clinic
Full name of responsible person
Ayoub Barzegarnejad
Street address
Amir Mazandarani Street, Moustafavian Specialty Clinic
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
omid.7803@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Pharmacy
Full name of responsible person
Dr Mohammad Azadbakht
Street address
Farah abad street
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
Azadbakhtm@hotmail.com
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, Faculty of Pharmacy
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
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Sojoudi
Position
Pharmacy Student of Sari University of Medical Sciences
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Farah Abad Street
City
Sari
Province
Mazandaran
Postal code
4818974356
Phone
+98 11 3354 2472
Email
Omid.6120@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mohammad Azadbakht
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Farah Abad Street
City
Sari
Province
Mazandaran
Postal code
4847191971
Phone
+98 11 3354 2472
Email
Azadbakhtm@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Omid Sojoudi
Position
Pharmacy student of Sari University of Medical Sciences
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Farah Abad Street
City
Sari
Province
Mazandaran
Postal code
4818974356
Phone
+98 11 3328 2126
Email
Omid.6120@yahoo.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
En Results from clinical trials
When the data will become available and for how long
2 Month after print results
To whom data/document is available
Use of results is allowed only with the mention of the source
Under which criteria data/document could be used
for researchers working in Mazandaran University of Medical Sciences
From where data/document is obtainable
Omid sojoudi 00 98 9382878294
What processes are involved for a request to access data/document
Request from the researcher
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