The complications of the drugs used in osteoarthritis have led the researchers to use chondroitin sulfate and hyaluronic acid in patients with knee osteoarthritis and to evaluate and compare the effectiveness of treatment with chondroitin sulfate and hyaluronic acid in patients with knee osteoarthritis Pay attention
Design
Clinical trials with control group, one blind
Settings and conduct
Ayatollah Mousavi Hospital in Zanjan
Participants/Inclusion and exclusion criteria
Entry requirements: Patients with knee osteoarthritis with clinical and para-clinical diagnostic criteria
Conditions of non-arrival: patient dissatisfaction؛ hypersensitivity to hyaluronic acid؛ localized skin infection ؛unilateral DJD
Intervention groups
For each patient, both drugs (chondroitin sulfate-hyaluronic acid) injected into the right knee and hyaluronic acid were injected into the left knee. Then, in four, one month, three months, six months and nine months, clinical symptoms including pain, joint dryness and distance traveled through the checklist were evaluated.
Main outcome variables
Pain; joint range of motion; distance traveled
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190226042854N1
Registration date:2019-03-17, 1397/12/26
Registration timing:retrospective
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Asghar Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3741 2698
Email address
asghar.abedi71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Evaluating and comparing the efficacy of treatment with chondroitin sulfate and hyaluronic acid in patients with knee osteoarthritis
Public title
The effect of arthromac plus in the treatment of knee arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee osteoarthritis with clinical and para-clinical diagnostic keratitis suffer from bilateral knee osteoarthritis.
Exclusion criteria:
No patient satisfaction
Hyaluronic acid hypersensitivity
Local skin infection
Unilateral DJD
Age
From 50 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
54
More than 1 sample in each individual
Number of samples in each individual:
2
The patient's left and right knees
Actual sample size reached:
54
More than 1 sample in each individual
Actual sample size in each individual:
2
The patient's left and right knees
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
A complete explanation was given to the patient about studying and comparing the therapeutic effect of drugs. The patient then received both ampoule arthromac plus (hyaluronic acid-chondrotin sulfate) and arthromac (hyaluronic acid). Then arthromac Plus was injected in the right knee and arthromac in the left knee. The patient did not have any information about the type of injectable drug in his knees. The appearance of both ampoules was identical (milky). During the study, only a physician was aware of the type of injected drug on the knees and information was collected by the same physician. The other person, including the patient himself and the nurse and the medical staff, did not know the type of injected drug on the knees.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Specialized and Specialized Training Center of Ayatollah Mousavi, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-04-14, 1397/01/25
Ethics committee reference number
IR.ZUMS.REC.1397.174
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
Pain score in patients after drug injection based on VAS
Timepoint
1 month, 3 months, 6 months, 9 months
Method of measurement
questionnaire
Secondary outcomes
1
Description
Pain; Range of motion ; distance traveled
Timepoint
1 month, 3 months, 6 months, 9 months
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Patient right knee; In this group injections of intravenous injection of Arthromc plus, containing 3 ml of hyaluronic acid-chondrocyte sulfate, at a concentration of 20 MG / ML, made in France, NOVATEX BIOENGINEERING.
Category
Treatment - Drugs
2
Description
Control group: The left knee was injected intradermally. In this group, the injection of intravenous injection of artrocomic ampoule containing 3 ml of hyaluronic acid at a concentration of 20 MG / ml, made in France, NOVATEX BIOENGINEERING.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Asghar Abedi
Street address
mousavi hospital - gavazang road - zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Fax
+98 24 3342 4774
Email
asghar.abedi71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Shoghli
Street address
mousavi hospital - gavazang road - zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 4771
Email
pr@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
asghar abedi
Position
دانشجوی پزشکی
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Aban Complex, Azadegan Town
City
Zanjan
Province
Zanjan
Postal code
5518853347
Phone
+98 41 3741 2698
Email
asghar.abedi71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Aghar Abedi
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Aban Complex, Azadegan Town
City
zanjan
Province
Zanjan
Postal code
5518853347
Phone
+98 41 3741 2698
Email
asghar.abedi71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
asghar abedi
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Aban Complex, Azadegan Town
City
Zanjan
Province
Zanjan
Postal code
5518853347
Phone
+98 41 3741 2698
Email
asghar.abedi71@gmail.com
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