In this study, the effects of clove jell in the treatment for premature ejaculation are compared to placebo.This study is a double-blind, placebo-control, phase II randomized clinical trial with a sample size of 50 patients. All of the subjects with intravaginal ejaculation latency time less than 1 minutes would be enrolled in the study after considering the general state of health and rule out of erectile dysfunction. After random allocation, subjects divided into two groups and each group received clove jell 1% or placebo. Participants take the drugs for 2 months. All of them record IELT (Intravaginal ejaculation latency time) with a stopwatch four weeks before the intervention and during it . Mean of IELT in the three last intercourse before and during intervention 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:IRCT2016013126298N1
Registration date:2016-02-13, 1394/11/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-13, 1394/11/24
Registrant information
Name
Ahmad Reza Sharifi Olounabadi
Name of organization / entity
Baqiatallah University of Medical Science, Department of Traditional Iranian Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 0060
Email address
a-sharifi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahed University of Medical Sciences
Expected recruitment start date
2016-02-14, 1394/11/25
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effect of clove jell in the treatment for premature ejaculation
Public title
effect of clove in premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:monogamous and heterosexual 18-40 years old man; Intravaginal ejaculation latency time less than 1 minutes; PEDT (Premature ejaculation diagnostic tool) questionnaire score more than eight
Exclusion criteria: History of severe or debilitating disease; diabetes; cardiac disease; liver disease; mental disease; thyroid dysfunction; addiction to any drugs or substances; pregnancy of wife; history of hypersensitivity to clove
Age
From 18 years old to 40 years old
Gender
Male
Phase
2
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
random allocation: table of random digits
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahed University of Medical Science
Street address
In front of the Holy Shrine of Imam Khomeini, khalij-e-Fars (Tehran-Qom) Highway
City
Tehran
Postal code
3319118651
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
shahed.REC.1394.55
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
ejaculation latency time
Timepoint
4 weeks before intervention and 2 months during it, 10 minutes before intercourse