Protocol summary

Summary
The purpose of the present study is to investigate and compare the potential effects of Hyaluronic acid and atorvastatin on the symptoms of knee osteoarthritis. This open, randomized, parallel study will be conducted on patients with knee osteoarthritis according to American College of Rheumatology (ACR) criteria. Patients will be enrolled from outpatient clinic of Imam Reza Hospital, Mashhad, Iran. Eligible patients are those who meet the ACR criteria of primary knee osteoarthritis, radiologically ascertained grade I or II of knee osteoarthritis on the Kellgren-Lawrence scale, had a pain score=>60 (maximum 100) and age 50-70 years. Patients are not eligible if they have: secondary osteoarthritis, systemic disease like diabetes, history of Inflammatory arthritis, sever knee deformity (varus or valgus >50 degree), history of coagulopathy, sever cardiovascular disease and active infections. We will divide them randomly (via a random number table) into two groups; Group 1 (n=35) will receive intra-articular Hyaluronic acid (Hyaluron HEXAL 20 mg, Germany) each week for three weeks, and group 2 (n=35) will receive oral atorvastatin 40 mg/day orally (Sobhan Darou, Tehran, Iran) for six months. We will train all patients to answer the WOMAC questioner. They will be permitted to continue their usual treatment with analgesics and non-steroidal anti-inflammatory drugs (NSAIDs). However, they are urged not to use analgesics and NSAIDs 48 hours before physician visit to prevent scrambled test results. Symptoms will be scored by WOMAC index at enrollment and every month up to 6 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504141479N4
Registration date: 2015-08-17, 1394/05/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-17, 1394/05/26
Registrant information
Name
Mohammadhassan Jokar
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 8818
Email address
jokarmh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice president of Mashhad University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-07-06, 1393/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to Compare between the efficacy of of intra-articular Hyaluronic acid and oral atorvastatin in reducing pain, stiffness, and function of the knee in patients with mild to moderate knee osteoarthritis
Public title
The effects of Hyaluronic acid and Atorvastatin on knee arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria 1- Knee osteoarthritis according to ACR criteria 2- Age 50-70 years 3- Radiologically ascertained grade I or II of knee osteoarthritis on the Kellgren-Lawrence scale 4- Pain score=>60 (maximum 100) Exclusion criteria 1- Secondary osteoarthritis 2- Systemic disease like diabetes 3- History of Inflammatory arthritis 4- Sever knee deformity (varus or valgus >50 degree) 5-History of coagulopathies 6- Sever cardiovascular disease 7- Active infections 8- Immunologic disorders 9- Taking anticoagulants 10- Hb<11 mg/dl, platelet count<150000/dl
Age
From 50 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: via a random number table

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical sciences, Daneshgah street
City
Mashhad
Postal code
9177899191
Approval date
2013-03-02, 1391/12/12
Ethics committee reference number
IR.MUMS.REC.1391.901

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Gonarthrosis [arthrosis of knee]

Primary outcomes

1

Description
Knee osteoarthritis symptoms: knee pain, knee sitffness and knee function
Timepoint
At enrollment and after intervention : every month up to 6 months.
Method of measurement
WOMAC questionnaire

Secondary outcomes

1

Description
Drug side effects: in group 1: hypersensitivity reaction in injection site and exacerbation of knee pain. In group 2: musculoskeletal pain, skin rash and gastrointestinal symptoms
Timepoint
Every 1 month after intervention up to 6 months
Method of measurement
Taking history

Intervention groups

1

Description
Group 1: After sterilizing the injection site, we inject one ampoule of Hyaluronic acid (Hyaluron® HEXAL, Germany,20mg/2cc) into the knee joint. We repeat the injection each week for three times
Category
Treatment - Drugs

2

Description
Group 2: Oral atorvastatin 40 mg (Sobhan Darou, Tehran, Iran) one tablet daily for 6 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hassan Jokar
Street address
Daneshgah street
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice president for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah street
City
Mshhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice president for research, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Hassan Jokar
Position
Rheumatologist, Associated Professor
Other areas of specialty/work
Street address
Daneshgah street
City
Mashhad
Postal code
9177899191
Phone
+98 51 3859 8818
Fax
+98 51 3859 8818
Email
jokarmh@mums.ac.ir jokarmh@gmail.com mirfeiziz@mums.ac.ir
Web page address
http://my.mums.ac.ir/default.aspx

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad university of Medical Sciences
Full name of responsible person
Mohammad Hassan Jokar
Position
Rheumatologist, Associated Professor
Other areas of specialty/work
Street address
Daneshgah street
City
Mashhad
Postal code
9177899191
Phone
+98 51 3859 8818
Fax
+98 51 3859 8818
Email
jokarmh@mums.ac.ir jokarmh@gmail.com
Web page address
http://my.mums.ac.ir/default.aspx

Person responsible for updating data

Contact
Name of organization / entity
Mashhad university of Medical Sciences
Full name of responsible person
Mohammad Hassan Jokar
Position
Associated professor
Other areas of specialty/work
Street address
Daneshgah street
City
Mashhad
Postal code
9177899191
Phone
+98 518598818
Fax
+98 518598818
Email
Jokarmh@mums.ac.ir
Web page address
http://my.mums.ac.ir/default.aspx

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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