Comparing the effectiveness of tamsulosin and ginseng drug combination with tamsulosin and licorice on clinical symptoms of patients with benign prostate hyperplasia
Comparing the effectiveness of the pharmaceutical combination of tamsulosin and ginseng with tamsulosin and licorice on clinical symptoms of patients with benign prostatic hyperplasia
Design
A controlled clinical trial with parallel groups, without blinding, will be conducted in Phase 3 on 72 people. The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted at Shahid Beheshti Hospital in Hamedan on patients with benign prostatic hyperplasia. In this study, patients will be randomly assigned to two treatment groups: ginseng capsules plus tamsulosin capsules and the second group will receive licorice tablets and tamsulosin. Both groups will be followed up for three months in terms of clinical symptoms.
Participants/Inclusion and exclusion criteria
Participants will be patients with benign prostatic hyperplasia. Inclusion criteria for the study were age 50 to 70 years, IPSS equal to or greater than 8, PSA less than 4, residual urine volume less than 150 cc, and prostate volume greater than 30 cc. Exclusion criteria included history of treatment with anticholinergic drugs in the past month, history of prostate surgery, and recurrent or recurrent urinary tract infections.
Intervention groups
Group 1: Ginseng capsules from Gol Daru Pharmaceutical Company (one every 12 hours) and Tamsulosin 0.4 mg capsules from Razak Pharmaceutical Company (one daily before bedtime) will be received.
Group 2: Licorice tablets from Iran Daruk Pharmaceutical Company (one every 12 hours) and Tamsulosin 0.4 mg from Razak Pharmaceutical Company (one daily before bedtime).
Main outcome variables
The main outcomes are urinary symptoms, sexual function, and medication side effects.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N44
Registration date:2025-03-01, 1403/12/11
Registration timing:prospective
Last update:2025-03-01, 1403/12/11
Update count:0
Registration date
2025-03-01, 1403/12/11
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-04, 1404/01/15
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of tamsulosin and ginseng drug combination with tamsulosin and licorice on clinical symptoms of patients with benign prostate hyperplasia
Public title
Comparing the effects of amsulosin and ginseng with tamsulosin and licorice on clinical symptoms of benign prostatic hyperplasia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
IPSS ≥ 8
PSA<4
Residual urine volume<150 cc
Prostate volume > 30 cc
Exclusion criteria:
History of treatment with anticholinergic drugs in the past month
Having a urinary tract infection
History of prostate surgery
Having neurological disorders such as Parkinson's or stroke
Age
From 50 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization and sealed envelope methods will be used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
ُShahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2025-02-15, 1403/11/27
Ethics committee reference number
IR.UMSHA.REC.1403.838
Health conditions studied
1
Description of health condition studied
Benign Prostate Hyperplasia
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate
Primary outcomes
1
Description
Changes in urinary symptoms
Timepoint
Before treatment and 3 months after treatment
Method of measurement
IPSS Urinary Function Questionnaire
2
Description
Changes in patients' sexual function
Timepoint
Before treatment and 3 months after treatment
Method of measurement
With the IIEF sexual function questionnaire
Secondary outcomes
1
Description
Occurrence of drug side effects
Timepoint
From the start of treatment to the end of treatment
Method of measurement
Clinical examination and questioning of patients
Intervention groups
1
Description
Intervention group: They will take one ginseng capsule every 12 hours and one tamsulosin capsule 0.4 mg daily before bedtime.
Category
Treatment - Drugs
2
Description
Intervention group: They will take one licorice tablet every 12 hours and one tamsulosin 0.4 mg daily before bedtime for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Behzad Mohammad Souri
Street address
Eram Blv
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0283
Email
drbehzadsoori@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Alireza Soltanian
Street address
Shahid Fahmide
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Mohammad Souri
Position
Associated Profesor
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
Eram Blvd
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0572
Fax
Email
drbehzadsoori@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
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
Yes - There is 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
No more information's
When the data will become available and for how long
From Feb 2026 onwards it is permissible
To whom data/document is available
Clinical professionals and Researchers in all fields
Under which criteria data/document could be used
For treatment of patients and develop research and science
From where data/document is obtainable
Correspond to the email address of the scientific responsible for the study
What processes are involved for a request to access data/document