Comparison of clinical effects of sodium mannuronate and salicylate ointments in the reduction of activity and symptoms of disease in patients with osteoarthritis
In this double-blind randomized controlled clinical trial (double-blind means that the patients and researchers are unknown about what kind of treatment has been provided). We use sodium mannuronate ointment as an anti-inflammatory drug in treatment of patients with osteoarthritis and effectiveness of this drug in involved patients will be compared with salicylate as another anti-inflammatory drugs. Our samples are 50 patients with osteoarthritis in the age range of 35 to 75 years, according to the diagnostic criteria of American College of Rheumatology will be selected at the first visit by a specialist in rheumatology in Rheumatology Research Center, Shariati Hospital and for each patients, the questionnaire will be completed. In the selection of these patients, no history of autoimmune disorders, infectious diseases, cancers and malignancies, as well as non-current pregnancy or breast feeding is considered. Then patients with block randomized method will be divided into control and treatment groups. Treatment group will be treated topically 3 times per day for 30 days with non-steroidal ointment called mannuronate sodium which its effective material has been produced in department of immunology, Tehran University of Medical Sciences and then is packaged by Tropical Drug Industry Kish Co. Control group is treated topically 3 times per day for 30 days with salicylate ointment produced by Sobhan Darou Co. After the treatment period, patients are re-examined by a specialist in rheumatology and related questionnaire is completed. The results will be compared to each other and therapeutic effect of this medication in reduction of the symptoms of osteoarthritis will be examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014113013739N3
Registration date:2015-02-15, 1393/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Abbas Mirshafiey
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4913
Email address
mirshafiey@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of clinical effects of sodium mannuronate and salicylate ointments in the reduction of activity and symptoms of disease in patients with osteoarthritis
Public title
Effect of sodium mannuronate ointment in osteoarthritis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with osteoarthritis in the age range of 35 to 75 years, according to the diagnostic criteria of American College of Rheumatology which at the first visit by a specialist in rheumatology and then by laboratory and radiological parameters are diagnosed.
Exclusion criteria: history of fever and infectious diseases, pregnancy and breast feeding, other autoimmune diseases, cancers and malignancies, the involvement of patients in the other clinical trials during the past 4 weeks, other diseases simultaneously (hepatic, nephrotic, hematologic, gastrointestinal, endocrine, cardiovascular, respiratory, neurologic or cephalic)
Age
From 35 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina Street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
93-01-27-24686-131381
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.0
ICD-10 code description
Polyartherosis
Primary outcomes
1
Description
Osteoarthritis activity
Timepoint
Before intervention and one month after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Pain
Timepoint
Before intervention and one month after intervention
Method of measurement
Questionnaire
2
Description
Stiffness
Timepoint
Before intervention and one month after intervention
Method of measurement
Questionnaire
3
Description
Physical performance
Timepoint
Before intervention and one month after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group will be treated topically 3 times per day for 30 days with Salicylate ointment produced by Sobhan Darou Co.
Category
Treatment - Drugs
2
Description
Treatment group will be treated topically 3 times per day for 30 days with non-steroidal ointment called Mannuronate sodium which its effective material has been produced in department of immunology, Tehran University of Medical Sciences and then is packaged by Tropical Drug Industry Kish Co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences
Full name of responsible person
Ahmad Reza Jamshidi
Street address
Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences (Major supporter)
Full name of responsible person
Masoud Younesyan (Vice President for Research and Technology, Tehran University of MedicalSciences
Street address
Sixth floor of the Tehran University of Medical Sciences, Ghods Street, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences (Major supporter)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Mirshafiey
Position
Head Dept. of Pathobiology (Professor-PhD)
Other areas of specialty/work
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8895 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Mirshafiey
Position
Head Dept. of Pathobiology (Professor-PhD)
Other areas of specialty/work
Street address
Department of Pathobiology, School of Public Health, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8896 4913
Fax
Email
mirshafiey@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)