Comparison of the effects of Tamarind seed extract product (Tamarindus indica L.) with Sertraline in treatment of premature ejaculation
Design
This study is a randomized clinical trial study without a placebo group and a comparison in terms of the therapeutic effects of tamarind and sertraline on the treatment of premature ejaculation. 40 people (twenty people in each group) will be examined in this study from May 1403 to June 1403.
Settings and conduct
This study is a randomized clinical trial study without a placebo group and a comparison in terms of the therapeutic effects of tamarind and sertraline on the treatment of premature ejaculation. 40 people (twenty people in each group) will be examined in this study from May 1403 to June 1403.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1- Being monogamous and married for at least 6 months ago
2- age between 50-20 years old
3- A score greater than 8 in the PEDT questionnaire
4- Written and informed consent to participate in the study
Exclusion Criteria:
1- Unwillingness to continue studying
2- The occurrence of severe side effects that cause severe concern for the patient, or are dangerous for the patient's health as determined by the doctor
3- Failure to execute orders accurately and completely
4- Using treatments outside the study protocol
5- Not being able to accurately measure IELT
6- Chronic and long-term use of any kind of psychoactive drug or any type of narcotic drug
7- ulcerative colitis; Chronic constipation, digestive discomfort, kidney cleansing, high blood pressure
Intervention groups
Intervention group patients: oral intervention product, one capsule once a day for one month
Standard treatment group patients: Sertraline 50 mg once a day for one month
Main outcome variables
Duration of ejaculation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140926019295N4
Registration date:2024-04-09, 1403/01/21
Registration timing:prospective
Last update:2024-04-09, 1403/01/21
Update count:0
Registration date
2024-04-09, 1403/01/21
Registrant information
Name
Ali Sahraian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 9319
Email address
sahraian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-22, 1403/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of Tamarind seed extract product (Tamarindus indica L.) with Sertraline in treatment of premature ejaculation
Public title
Evaluation of the effects of Tamarind seed extract product (Tamarindus indica L.) with Sertraline in treatment of premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being monogamous and married for at least 6 months ago
age between 50-20 years old
PEDT questionnaire score greater than 8
Written and informed consent to participate in the study
Exclusion criteria:
Use of treatments outside the study protocol
ulcerative colitis; Chronic constipation, digestive discomfort, kidney cleansing, high blood pressure
Not being able to accurately measure the IELT score
Chronic and permanent use of any type of psychoactive drug or any type of narcotic drug
Age
From 20 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is simple randomization. The randomization unit is individual and the patient randomization tool is a table of random numbers using with computer. The starting point was completely random (choosing a number on the table with eyes closed) and choosing the direction of movement in the table in the downward direction. Patients are randomly placed in one of the study groups with the help of a random number table and receive the relevant intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluator and the statistical analyst of the results will be blinded. The capsules of the drug and the standard drug have the same shape, and after being filled, they are packed in packages of 30 pieces that are completely similar in terms of shape.
Only the researcher can decipher the contents of each capsule package based on the initial form stored of the randomization results. The person responsible for delivering the medicine, the patient, the doctor, the person responsible for evaluating the results will not know about the coding.
The results of group therapy and intervention will be delivered to the statistical analyst under the titles of groups A and B.
Placebo
Not 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 Sciences
Street address
Karim Khan Zand St. Faculty of Medicine
City
Shiraz
Province
Fars
Postal code
7144714189
Approval date
2024-03-02, 1402/12/12
Ethics committee reference number
IR.SUMS.MED.REC.1402.542
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
Time of Ejaculation ( From Vaginal Entrance to Ejaculation )
Timepoint
The Time of Ejaculation at the Beginning of the Study ( Before the Intervention) and 4 weeks after the start of Drug
Method of measurement
Measure the time in seconds by the stopwatch by the patient's wife
Secondary outcomes
empty
Intervention groups
1
Description
Tamarind seed capsule is standardized to contain at least 80 mg of active ingredient, it will be consumed once a day for one month, this drug is made by Dayan Teb Elixir Company.
Category
Treatment - Drugs
2
Description
Sertraline 50 mg will be taken once a day for one month, manufactured by Octorco pharmaceutical company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnsina Hospital
Full name of responsible person
Payam Sadeghi
Street address
Hafezie avenue
City
Shiraz
Province
Fars
Postal code
7144676541
Phone
+98 71 3228 9604
Email
payamsadeghi68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Shiraz, Zand St., Shiraz University of Medical Sciences Central Building
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
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 Sciences
Proportion provided by this source
50
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
Shiraz University of Medical Sciences
Full name of responsible person
Payam Sadeghi
Position
Psychiatry Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blv. Hafez hospital- psychiatry department
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3647 9531
Email
payamsadeghi68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Sahraian
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Hafez Hospital ,Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7144734189
Phone
+98 71 3647 9531
Email
sahraian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Payam Sadeghi
Position
Psychiary Rezident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Chamran Blv. Hafez hospital- psychiatry department
City
Shiraz
Province
Fars
Postal code
۳۴۷۸۶-۷۱۹۴۶
Phone
+98 71 3647 9319
Email
payamsadeghi68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available