Effect of N-acetyl cysteine supplementation versus placebo on clinical outcomes in women with chronic pelvic pain syndrome: a double-blind randomized clinical trial
To assess the effect of N-acetyl cysteine supplementation versus placebo on clinical outcomes in women with chronic pelvic pain syndrome
Design
This is a double-blind randomized clinical trial, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible women with chronic pelvic pain syndrome referring to the 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. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 50 years,
Women with chronic pelvic pain syndrome for at least 6 months,
Exclusion criteria:
Presence of pathologic or infamous reason for chronic pelvic pain,
Mild symptoms (the score less than 15 based on NIH-CPSI questionnaire),
Chronic liver or renal disease,
Kidney stone or urogenital tract infection,
History of surgery of urogenital tract,
Contraindication of N-acetyl cysteine
Intervention groups
Intervention group:
Amitriptyline 25 mg daily plus N-acetylcysteine tablets (manufactured by Osweh Pharmaceutical Co., Tehran, Iran) 600 mg every 12 hours for 2 months
Control group:
Amitriptyline 25 mg daily plus placebo tablets (manufactured by Shahid Beheshti School of Pharmacy) every 12 hours for 2 months
Main outcome variables
Primary outcome:
Clinical symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N376
Registration date:2021-01-22, 1399/11/03
Registration timing:prospective
Last update:2021-01-22, 1399/11/03
Update count:0
Registration date
2021-01-22, 1399/11/03
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
2021-04-21, 1400/02/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-acetyl cysteine supplementation versus placebo on clinical outcomes in women with chronic pelvic pain syndrome: a double-blind randomized clinical trial
Public title
Effect of N-acetyl cysteine supplementation versus placebo on clinical outcomes in women with chronic pelvic pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 50 years,
Women with chronic pelvic pain syndrome for at least 6 months,
Exclusion criteria:
Presence of pathologic or infamous reason for chronic pelvic pain,
Mild symptoms (the score less than 15 based on NIH-CPSI questionnaire),
Chronic liver or renal disease,
Kidney stone or urogenital tract infection,
History of surgery of urogenital tract,
Contraindication of N-acetyl cysteine
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
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 triple-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
2020-10-24, 1399/08/03
Ethics committee reference number
IR.UMSHA.REC.1399.629
Health conditions studied
1
Description of health condition studied
Chronic pelvic pain syndrome
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Clinical symptoms
Timepoint
Before the intervention and 4 and 8 weeks after that
Method of measurement
Using the National Institutes of Health - Chronic Prostatitis Symptom Index (NIH-CPSI) standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Amitriptyline 25 mg daily plus N-acetyl cysteine tablets (manufactured by Osweh Pharmaceutical Co., Tehran, Iran) 600 mg every 12 hours for 2 months
Category
Treatment - Drugs
2
Description
Control group: Amitriptyline 25 mg daily plus placebo tablets (manufactured by Shahid Beheshti School of Pharmacy) every 12 hours for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan city
Full name of responsible person
Somayeh Rahymy
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
rhymy2958@gmail.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
Somayeh Rahymy
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Genetics
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
rhymy2958@gmail.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
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