To assess the effect of duloxetine versus amitriptyline on clinical outcomes of female with chronic pelvic pain syndrome
Design
This is a double-blind randomized clinical trial, phase III. The control group receives standard treatment. In this trial the eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Beheshti Hospital in Hamadan city on 48 eligible patients with chronic pelvic pain syndrome. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Chronic pelvic pain syndrome for more than 6 months
Being literate
Exclusion criteria:
Pregnancy or breastfeeding
Suffering from endometriosis, ovarian cyst, adenomyosis, fibroid or genital malignancy
Gastrointestinal diseases including irritable bowel syndrome or inflammatory bowel disease
History of previous hip surgery
Genitourinary infection
Cognitive or mental disorders
Kidney and liver dysfunction
History of alcohol and substance abuse
Intervention groups
Intervention group:
Duloxetine tablets 30 mg daily for one week then 60 mg daily for 8 weeks
Control group:
Amitriptyline tablets 25 mg daily for one week then 50 mg daily for 8 weeks
Main outcome variables
Primary outcome:
Improvement of clinical symptoms
The rate of overall response to treatment
Secondary outcome:
Occurrence of side effects (nausea, vomiting)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N457
Registration date:2023-01-10, 1401/10/20
Registration timing:registered_while_recruiting
Last update:2023-01-10, 1401/10/20
Update count:0
Registration date
2023-01-10, 1401/10/20
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
2023-01-05, 1401/10/15
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect duloxetine versus amitriptyline on clinical outcomes of female with chronic pelvic pain syndrome: a double-blind randomized clinical trial
Public title
Effect duloxetine versus amitriptyline on clinical outcomes of female with chronic pelvic pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Chronic pelvic pain syndrome for more than 6 months
Exclusion criteria:
Pregnancy or breastfeeding
Suffering from endometriosis, ovarian cyst, adenomyosis, fibroid or genital malignancy
Gastrointestinal diseases including irritable bowel syndrome or inflammatory bowel disease
History of previous hip surgery
Genitourinary infection
Cognitive or mental disorders
Kidney and liver dysfunction
History of alcohol and substance abuse
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
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 drugs will be given in coded envelopes. 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
Not 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
2022-10-23, 1401/08/01
Ethics committee reference number
IR.UMSHA.REC.1401.621
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
Improvement of clinical symptoms (pain, difficulty in defecation)
Timepoint
Before the intervention and one and two months after that
Method of measurement
Using the National Institutes of Health Chronic Syndrome Symptom Index (NIH-CSSI)
2
Description
The rate of overall response to treatment
Timepoint
Two months after the intervention
Method of measurement
Using the Global Response Assessment (GRA) questionnaire
Secondary outcomes
1
Description
Occurrence of side effects (nausea, vomiting)
Timepoint
one and two months after intervention
Method of measurement
With history taking
Intervention groups
1
Description
Intervention group: Duloxetine tablets 30 mg daily for one week then 60 mg daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Amitriptyline tablets 25 mg daily for one week then 50 mg daily for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Rojan Ghaderzadeh
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
rojan.ghz7799@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
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
Rojan Ghaderzadeh
Position
Student of Pharmacy
Latest degree
Medical doctor
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
rojan.ghz7799@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