Effect of N-acetyl Cysteine versus placebo as adjunct therapy on the clinical outcomes in patients with chronic non-bacterial prostatitis: a double-blind randomized clinical trial
To assess the effect of N-acetyl Cysteine versus placebo as adjunct therapy on the clinical outcomes in patients with chronic non-bacterial prostatitis
Design
This is a double-blind randomized clinical trial, phase II, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with chronic non-bacterial prostatitis who will refer to Shahid Beheshti Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 to 40 years,
Chronic non-bacterial prostatitis for at least 6 months,
The severity of the clinical symptoms at least 15 based on the NIH-CPSI questionnaire
Exclusion criteria:
Taking anti-androgen medications in the past 6 months,
Taking alpha-blockers or other antibiotics in the past month,
Taking antioxidant or anti-inflammatory or corticosteroids medications in the past month,
Genitourinary tract infection in the past 6 months,
Other diseases of the genitourinary system,
History of genitourinary system surgery,
Chronic liver or kidney disease
Intervention groups
Intervention group:
Tamsulosin tablets 0.4 mg (manufactured by Reihana Pharmaceutical Company) daily plus N-acetyl Cysteine tablets 600 mg (manufactured Ave Sina Pharmaceutical Company) every 12 hours for one month
Control group:
Tamsulosin tablets 0.4 mg (manufactured by Reihana Pharmaceutical Company) daily plus placebo tablets (manufactured by the laboratory of the School of Pharmacy, Hamadan University of Medical Sciences) every 12 hours for one month
Main outcome variables
Primary outcome:
The patient's clinical outcome, the severity of pain, the quality of urination
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N318
Registration date:2019-12-03, 1398/09/12
Registration timing:prospective
Last update:2019-12-03, 1398/09/12
Update count:0
Registration date
2019-12-03, 1398/09/12
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-acetyl Cysteine versus placebo as adjunct therapy on the clinical outcomes in patients with chronic non-bacterial prostatitis: a double-blind randomized clinical trial
Public title
Effect of N-acetyl Cysteine versus placebo as adjunct therapy on the clinical outcomes in patients with chronic non-bacterial prostatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 40 years,
Chronic non-bacterial prostatitis for at least 6 months,
The severity of the clinical symptoms at least 15 based on the NIH-CPSI questionnaire
Exclusion criteria:
Taking anti-androgen medications in the past 6 months,
Taking alpha-blockers or other antibiotics in the past month,
Taking antioxidant or anti-inflammatory or corticosteroids medications in the past month,
Genitourinary tract infection in the past 6 months,
Other diseases of the genitourinary system,
History of genitourinary system surgery,
Chronic liver or kidney disease
Age
From 20 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.UMSHA.REC.1398.693
Health conditions studied
1
Description of health condition studied
Non-bacterial prostatitis
ICD-10 code
N41.1
ICD-10 code description
Chronic prostatitis
Primary outcomes
1
Description
The patient's clinical outcome
Timepoint
One, two, and three months after the intervention
Method of measurement
by using NIH-CPSI standard questionnaire
2
Description
The severity of pain
Timepoint
One, two, and three months after the intervention
Method of measurement
By using Visual Analog Scale (VAS)
3
Description
The quality of urination
Timepoint
One, two, and three months after the intervention
Method of measurement
By taking history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tamsulosin tablets 0.4 mg (manufactured by Reihana Pharmaceutical Company) daily plus N-acetyl Cysteine tablets 600 mg (manufactured Ave Sina Pharmaceutical Company) every 12 hours for one month
Category
Treatment - Drugs
2
Description
Control group: Tamsulosin tablets 0.4 mg (manufactured by Reihana Pharmaceutical Company) daily plus placebo tablets (manufactured by laboratory of the School of Pharmacy, Hamadan University of Medical Sciences) every 12 hours for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan city
Full name of responsible person
Dr Maryam Mehrpooya
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
m_mehrpooya2003@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
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
Dr Maryam Mehrpooya
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Maryam Mehrpooya
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
m_mehrpooya2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be 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