In this double-blind, placebo-control, randomized clinical trial, the effects of Tamarind seed product on management of premature ejaculation are compare to Paroxetine and placebo. All of the subjects would be enrolled in the study after considering the general state of health, kidney and liver function tests and rejection of erection problems. After random allocation, subjects divided into three groups and each group received Tamarin, Paroxetine 20 mg or placebo. Participants take the drugs for 30 days. All of them record IELT (Intravaginal ejaculation latency time) with a stopwatch two weeks before and during treatment. Mean of IELT in the three last intercourse before and during treatment will be compared. The PEDT (premature ejaculation diagnostic tool) questionnaire will be completed for each participant at the beginning and end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051422281N1
Registration date:2015-06-23, 1394/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-23, 1394/04/02
Registrant information
Name
Abdullah Homayunfar
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 712337589
Email address
homayon1351@irimc.org
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Tamarind seed product (Tamarindus indica L.) with Paroxetine and placebo in treatment of premature ejaculation
Public title
The effects of Tamarind seed product in treatment of premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Intravaginal ejaculation latency time less than 2 minutes; Monogamy; People who have been married at least for 6 months; Age between 20- 50 years old; PEDT (Premature ejaculation diagnostic test) score more than eight / Exclusion criteria: History of mental or physical disease such diabetes; cardiac disease; liver or kidney disease; addiction to any drugs or substances; Contraindications of taking sSSRI (Selective serotonin re-uptake inhibitors)
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand St.
City
Shiraz
Postal code
7134814336
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
CT-9376-7396
Health conditions studied
1
Description of health condition studied
Premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation
Primary outcomes
1
Description
Intrvaginal ejaculation latency time
Timepoint
Before and after study
Method of measurement
Stopwatch
Secondary outcomes
1
Description
Premature ejaculation diagnostic test score
Timepoint
Before and after study
Method of measurement
Questionnaire
Intervention groups
1
Description
Paroxetine 20 mg daily for 30 days
Category
Treatment - Drugs
2
Description
Tamarind seed product one cap. daily for 30 days
Category
Treatment - Drugs
3
Description
Placebo one cap. daily for 30 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Traditional medicine clinic, Motahhri clinical complex
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Science, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Science
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
Research center of tradirional medicine and history of medicine
Full name of responsible person
Abdullah Homayunfar
Position
Resident
Other areas of specialty/work
Street address
Research center of tradirional medicine and history of medicine, Medical College, Zand street
City
Shiraz
Postal code
7134845794
Phone
+98 76 3233 7589
Fax
+98 76 3233 8476
Email
homayunfar@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical College
Full name of responsible person
Dr. Ali reza Amin sharifi
Position
Associated Professor of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Medical College, Zand street
City
Shiraz
Postal code
Phone
+98 76 3233 1006
Fax
Email
aminsharifi_ar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center of Traditional Medicine and History of Medicine
Full name of responsible person
Abdullah Homayunfar
Position
Resident
Other areas of specialty/work
Street address
Research Center of Traditional Medicine and History of Medicine, Medical College, Zand street
City
Shiraz
Postal code
7134845794
Phone
+98 71 3233 7589
Fax
+98 71 3233 8476
Email
homayunfar@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)