The effectiveness of Turmeric extract (Curcuma) versus Russian olive extract on the pain, function and quality of life in the patients with knee osteoarthritis
We aim to evaluate and compare the effect of two important drugs on pain relief and improvement of symptoms and function of patients with knee osteoarthritis.
Design
A phase 3 and single blind clinical trial with standard design (parallel controls), will be performed on 50 patients with knee osteoarthritis. Computer-based random assignments are as follows:
Group A: Oral treatment with Elartrit capsule + exercise training
Group B: Oral treatment with curcumin capsule + exercise training
Settings and conduct
Patients Referring to physical medicine clinics of Isfahan University of Medical Sciences (Alzahra & Amin) in 1398 and 1399
Participants/Inclusion and exclusion criteria
This study will be performed on 50 patients with mild to moderate knee osteoarthritis referred to physical medicine clinics of Isfahan University of Medical Sciences (Alzahra and Amin) in 1398.
The following patients will not be included in the study:
Other body joints involvement, systemic diseases, liver and kidney diseases, neuropathy, coagulation diseases, analgesic use before study
Intervention groups
Group A will be treated orally with 250 mg Elartrit capsules (containing Russian olive extract) of the Reyhaneh Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time. Group B will be treated orally with 370 mg capsules of curcumin of Razak Pharmaceutical Company (every 12 hours for 15 days, after meal). These patients will also be given stretching and strengthening exercises similar to Group A.
Main outcome variables
The VAS and KOOS questionnaire, and the Roles and Maudsley scale will be completed before treatment, 2 and 4 weeks after treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191216045760N1
Registration date:2020-02-15, 1398/11/26
Registration timing:prospective
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Sadegh Baradaran Mahdavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3236 0339
Email address
sadegh.b.mahdavi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-29, 1398/12/10
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Turmeric extract (Curcuma) versus Russian olive extract on the pain, function and quality of life in the patients with knee osteoarthritis
Public title
Comparison of Curcuma and Russian olive in the Treatment of Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 45 years
Patients diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria with symptoms for at least 3 months
Knee X-ray as grade 2 or 3 of Kellgren-Lawrence (K-L) classification
Patients' willingness to participate in the study after providing complete information about the project's goals
Exclusion criteria:
Clinical findings in other joints of the body such as hip, wrist or spine.
Evidence of neuropathy such as radiculopathy or peripheral neuropathy
Systemic inflammatory disease such as RA, AS
Fibromyalgia or endocrine and metabolic diseases
Corticosteroid use in the past 48 hours or intra-articular injection of Corticosteroid in the past 4 months
Taking NSAIDs in the past week
Psychiatric disease
Severe blood dyscrasia, coagulopathy, current warfarin use
Liver failure or liver tests more than 1.5 times of normal values
Biliary Disease
PUD or reflux history (GERD)
Renal Failure - Uncontrolled hypertension
Lack of medication compliance in the patient
Age
From 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using a computer-based randomization method, 50 people will be randomly assigned in to two groups (Group A, N=25 and Group B, N=25). The list will be given to the senior researcher. Patients will be assigned in to treatment A or treatment B by a designated peer after recruitment (by sequential sampling) according to the determined numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the primary investigator and supervisor are considered as physicians who are fully aware of the purpose of the study and the type of treatment. Patients will not be informed about the statistical purposes of the study and how the treatments are supposed to be compared. Patients will be informed of the name of their medication (as the treatment will be performed on an outpatient basis with the drug capsules available on the market). The researcher who evaluates the outcomes, as well as the statistical consultant and data analyst, does not know about the treatment A or B (Elartrit or curcumin, respectively) and the patients' names. Therefore, this study is a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-12-04, 1398/09/13
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.521
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain intensity
Timepoint
Before treatment, 2 and 4 weeks after treatment
Method of measurement
VAS (Visual Analogue Scale)
2
Description
Symptoms of disease and quality of life
Timepoint
Before treatment, 2 and 4 weeks after treatment
Method of measurement
Knee injury and Osteoarthritis Outcome Score (KOOS)
3
Description
Function
Timepoint
Before treatment, 2 and 4 weeks after treatment
Method of measurement
Roles and Maudsley score
Secondary outcomes
empty
Intervention groups
1
Description
The itervention group will be orally treated with 250 mg Elartrit capsules (containing Russian olive extract) of Reyhaneh Isfahan Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time.
Category
Treatment - Drugs
2
Description
The control group will be orally treated with 370 mg curcumin capsules of Razak Pharmaceutical Company (every 12 hours for 15 days, after meal). In addition, they will be instructed to perform stretching the hamstring and calf muscles as well as the quadriceps strengthening exercises for 30 days in the morning, noon and night, three times in each set and doing those for 30 seconds each time.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sadegh Baradaran Mahdavi
Street address
Sofeh Blvd
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir
2
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Sadegh Baradaran Mahdavi
Street address
Ebne Sina St
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۱۴۱
Phone
+98 31 3445 5051
Email
Amin@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Vahdatpour
Street address
Hezar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Alzahra@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sadegh Baradaran Mahdavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Close to Negin building, Ahmadieh alley, Taleghani St
City
Isfahan
Province
Isfehan
Postal code
8136833691
Phone
+98 31 3236 0339
Email
sadegh.b.mahdavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sadegh Baradaran Mahdavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Close to Negin building, Ahmadieh alley, Taleghani St
City
Isfahan
Province
Isfehan
Postal code
8136833691
Phone
+98 31 3236 0339
Email
sadegh.b.mahdavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sadegh Baradaran Mahdavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Close to Negin building, Ahmadieh alley, Taleghani St
City
Isfahan
Province
Isfehan
Postal code
8136833691
Phone
+98 31 3236 0339
Email
sadegh.b.mahdavi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
This study will publish information about the main outcomes and results of the study. There is currently no plan to disseminate other patient information even in an undetectable manner.
When the data will become available and for how long
After publishing the results
To whom data/document is available
No limit
Under which criteria data/document could be used
Citing the source
From where data/document is obtainable
Downloading the article from the journal's website or contacting the author of the article
What processes are involved for a request to access data/document
Downloading the article from the journal's website or contacting the author of the article