Evaluation of the possible therapeutic efficacy of topical glucosamine in patients with plaque psoriasis
Design
A double-blind randomized clinical trial with 30 eligible patients were randomly assigned to the R group (Right side as treatment) and the L group (Left side as treatment)
Settings and conduct
Patients with chronic plaque psoriasis who referred to the dermatology department of Imam Reza Hospital in Mashhad during the study were included in the study if they were eligible and were randomly assigned to the right and left groups of the body. This study was performed double-blindly so that patients and physicians did not know the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients of older than 18 years, Patients with plaque psoriasis
Exclusion criteria: Use of any topical or oral medication affecting the course of the disease in the last three months, Irregular attendance for visits, Occurrence of any complications
Intervention groups
30 patients of plaque psoriasis who indicated for topical treatment were enrolled in the study after declaring informed consent. The patient received glucosamine and placebo ointment and advised to use twice daily on every side of the body and totally be used for 8 weeks.
Main outcome variables
Despite a continuous reduction in modified PASI score in both groups, no significant differences were observed between the topical drug and the placebo
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200817048439N1
Registration date:2020-10-18, 1399/07/27
Registration timing:retrospective
Last update:2020-10-18, 1399/07/27
Update count:0
Registration date
2020-10-18, 1399/07/27
Registrant information
Name
Sadegh Dehghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2288
Email address
dehghanis931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2016-06-13, 1395/03/24
Actual recruitment start date
2016-05-09, 1395/02/20
Actual recruitment end date
2016-06-13, 1395/03/24
Trial completion date
2016-08-20, 1395/05/30
Scientific title
Evaluation of the effect and side effects of topical glucosamine in the treatment of patients with plaque psoriasis
Public title
Effect of glucosamine in the treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of older than 18 years
Patients with plaque psoriasis
Exclusion criteria:
Use of any topical or oral medication affecting the course of the disease in the last three months
Irregular attendance for visits
Occurrence of any complications
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
14
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the similarity of the placebo and the main drug, patients will not be informed of the type of intervention. On the other hand, the examining physician does not have information about the main characteristics of the patient and the type of intervention during the examination, and only the symptoms are examined and reported with numerical codes. Therefore, the study will be conducted double-blindly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Pardis Campus, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2016-02-13, 1394/11/24
Ethics committee reference number
IR.MUMS.REC.1396.656
Health conditions studied
1
Description of health condition studied
Psoriasis vulgaris
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
Psoriasis area and severity index (PASI)
Timepoint
Every two weeks
Method of measurement
Calculated by the severity index and psoriasis area formula
Secondary outcomes
empty
Intervention groups
1
Description
Glucosamine ointment: Topical glucosamine ointment was routinely used by patients twice a day on plaque lesions on one side of the body for a total of 8 weeks.
Category
Treatment - Drugs
2
Description
Placebo ointment: Topical placebo ointment was routinely used by patients twice a day on plaque lesions on one side of the body for a total of 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Cutaneous leishmaniasis research center
Full name of responsible person
Ahmadreza Taheri Bojd
Street address
Cutaneous leishmaniasis Research Center, Imam Reza Hospital, Ibn Sina St., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2078
Fax
+98 51 3802 2078
Email
src@mums.ac.ir
Web page address
https://src.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi Piadeh Gheibi
Street address
Deputy of Research and Technology, Ghorashi Building, University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ahmadreza Taheri Bojd
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Faculty of Medicine, Pardis Campus, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Fax
+98 51 3882 8560
Email
Taheriar@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Khadijeh Jamialahmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Faculty of Medicine, Pardis Campus, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Fax
+98 51 3882 8560
Email
Jamialahmadikh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sadegh Dehghani
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Medical Biotechnology
Street address
Faculty of Medicine, Pardis Campus, Azadi Square, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Fax
+98 51 3882 8560
Email
Dehghanis931@mums.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