To assess the effect of low-dose Naltrexone versus placebo in the treatment of chronic plaque Psoriasis
Design
This is a double-blind randomized clinical trial, phase II, in which 154 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with chronic plaque Psoriasis who will refer to Sina 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 who will examine the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Chronic plaque psoriasis
Exclusion criteria:
Pregnancy or breastfeeding,
Addiction to opium,
Renal or liver failure,
History of convulsion,
Severe mental disorder
Intervention groups
Intervention group:
Routine treatment as well as Naltrexone tablet 4.5 mg before sleep for 12 weeks
Control group:
Routine treatment as well as placebo tablet before sleep for 12 weeks
Main outcome variables
Primary outcome:
Improvement of the clinical signs of psoriasis
The quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N301
Registration date:2019-09-26, 1398/07/04
Registration timing:prospective
Last update:2019-09-26, 1398/07/04
Update count:0
Registration date
2019-09-26, 1398/07/04
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
2019-10-12, 1398/07/20
Expected recruitment end date
2020-05-09, 1399/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low-dose Naltrexone versus placebo in the treatment of chronic plaque psoriasis: a double-blind randomized clinical trial
Public title
Effect of low-dose Naltrexone versus placebo in the treatment of chronic plaque psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Chronic plaque psoriasis
Exclusion criteria:
Pregnancy or breastfeeding,
Addiction to opium,
Renal or liver failure,
History of convulsion,
Severe mental disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
154
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
2019-09-14, 1398/06/23
Ethics committee reference number
IR.UMSHA.REC.1398.473
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40
ICD-10 code description
Psoriasis
Primary outcomes
1
Description
Improvement of the clinical signs of psoriasis
Timepoint
12 weeks after the intervention
Method of measurement
Using Psoriasis Area Severity Index (PASI)
2
Description
The quality of life
Timepoint
12 weeks after the intervention
Method of measurement
Using Dermatology Life Quality Index (DLQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment as well as Naltrexone tablet 4.5 mg before sleep for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Routine treatment as well as placebo tablet before sleep for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Dr. Pedram ALirezaei
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
prc@umsha.ac.ir
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. Pedram ALirezaei
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
prc@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Pedram ALirezaei
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
prc@umsha.ac.ir
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