Determination of the efficacy of osvalin, piascledine and placebo in patients with knee osteoarthritis
Design
Three arm parallel group controlled randomized trial with blinded post treatment care and outcome assessment
Settings and conduct
Patients with knee osteoarthritis in Rasoul-e-Akram hospital, Tehran enrolled . These patients were divided into three groups and received osvalin, piascledine and placebo for three months respectively. The treatment outcomes were evaluated at 4, 8 and 12 weeks. Patients and doctors blinded of distribution of patients in the groups.
Participants/Inclusion and exclusion criteria
Patients with knee osteoarthritis
Intervention groups
Patients with knee osteoarthritis
Main outcome variables
Pain relief
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180316039112N2
Registration date:2019-08-05, 1398/05/14
Registration timing:retrospective
Last update:2019-08-05, 1398/05/14
Update count:0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
tayebramim@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
2019-02-20, 1397/12/01
Actual recruitment end date
2019-04-30, 1398/02/10
Trial completion date
2019-04-30, 1398/02/10
Scientific title
Comparison of the efficacy of osvalin, piascladine and placebo in the improvement of pain in patients with knee osteoarthritis
Public title
Effect of Osvalin and Piascladine on the treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee osteoarthritis
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
36
Actual sample size reached:
36
Randomization (investigator's opinion)
Randomized
Randomization description
The "Balanced Block Randomization" method was performed using statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study and the physician, as well as those responsible for evaluating the outcome, were kept blind to study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences