Evaluation of the effect of zinc supplementation in the treatment of patients with chronic pelvic pain syndrome
Design
A clinical trial with the control group, phase 2-3 is performed on 60 patients with parallel groups to evaluate the effect of zinc supplementation on pelvic floor pain.
Settings and conduct
This study is performed in Shahid Beheshti Hospital. Patients with chronic pelvic pain will be treated with either a zinc supplement or a placebo, and the amount of pelvic pain before and after treatment will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-65 years, diagnosis of chronic pelvic pain syndrome by a urologist, absence of underlying disease, free and informed written consent
Exclusion criteria: failure to take medication regularly, drug intolerance, taking zinc supplements during the last three months, and tendency to leave during the study
Intervention groups
Intervention group: Patients in this group, in addition to routine medications, will be treated with 30 mg of zinc supplements on a daily basis for one month.
Control group: Patients in this group will receive placebo tablets daily for one month in addition to routine medications.
Before the interventions, after two weeks and one month, the patients' pain and their chronic pelvic pain will be measured and compared by a questionnaire.
Main outcome variables
Pain, chronic pelvic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N12
Registration date:2022-06-22, 1401/04/01
Registration timing:prospective
Last update:2022-06-22, 1401/04/01
Update count:0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-22, 1401/04/31
Expected recruitment end date
2022-09-05, 1401/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of zinc supplementation in treatment of patients with chronic pelvic pain syndrome
Public title
Zinc supplementation and chronic pelvic pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years
Diagnosis of chronic pelvic pain syndrome by a urologist
Absence of underlying disease
Free and informed written consent
Exclusion criteria:
Failure to take medication regularly
Drug intolerance
Taking zinc supplements during the last 3 months
Tendency to leave during the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant's name and type of intervention (placebo or zinc sulfate) are written on a piece of paper and enclosed in an envelope. The envelopes containing the names of the participants will be placed in one box, and the envelopes containing the type of intervention will be placed in the other box. An uninformed person first picks up an envelope from the first box and then from the second box and gives it to the study coordinator. The coordinator writes down the participant's name and the selected intervention type. The process continues until all boxes are emptied.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study uses a placebo similar to zinc tablets that have similar appearance properties. Patients are not aware of the type of substances they receive and are unaware of their intervention type. Also, health care providers and evaluators of the results of interventions do not know the patient groups and the type of medication received.
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
Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
6516719657
Approval date
2022-05-06, 1401/02/16
Ethics committee reference number
IR.UMSHA.REC.1401.132
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
Pain
Timepoint
Before and after two weeks and one month after interventions
Method of measurement
Visual analog scale
2
Description
Chronic pelvic pain
Timepoint
Before and after two weeks and one month after interventions
Method of measurement
Chronic Prostatitis Symptom Index (NIH-CPSI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in this group, in addition to routine medications, treated with zinc supplements (made by Abian Company, containing 41.4 mg of zinc sulfate) will take daily intake for 1 month. Before the interventions, after 2 weeks and 1 month, the amount of pain and chronic pelvic pain will be measured and compared by a questionnaire.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive placebo tablets daily for one month in addition to routine medications. Before the interventions, after two weeks and one month, the patients' pain and their chronic pelvic pain will be measured and compared by a questionnaire.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan Shahid Beheshti Hospital
Full name of responsible person
Mahdi Vanaie
Street address
Eram Blvd.
City
Hamedan
Province
Hamadan
Postal code
6517953371
Phone
+98 913 410 8850
Email
mahvan13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
4th Floor, Hamedan University of Medical Sciences Headquarters, Shahid Fahmideh St., Pajouhesh Sq.
City
Hamadan
Province
Hamadan
Postal code
8174673118
Phone
+98 81 3838 1970
Email
reza.shokohi@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
Behruz Karkhanei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Eram Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0706
Email
bk13472000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maedeh Mohseni
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Eram Blvd.
City
Hamadan
Province
Hamadan
Postal code
8174673461
Phone
+98 81 3838 0706
Email
mao_mohseni@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahdi Vanaie
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Eram Blvd.
City
Hamadan
Province
Hamadan
Postal code
8174673461
Phone
+98 81 3838 0706
Email
Mahdi.vanaiee@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Hamedan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.