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Evaluation of the efficacy of Elaeagnus angustifolia extract (Elartrit) drug in comparison with meloxicam on pain relief and functional improvement of patients with knee osteoarthritis referred to physical medicine and rehabilitation clinics of Shiraz University of Medical Sciences

Protocol summary

Study aim
Evaluation of the efficacy of Elaeagnus angustifolia extract (Elartrit) in comparison to Meloxicam in pain relief and function improvement in patients with knee osteoarthritis
Design
Randomized double blind trial with a control group and an intervention group in parallel, with a single phase and a sample size of 60. The randomization method used is permutation block randomization.
Settings and conduct
Samples are selected from patients with knee osteoarthritis seeking medical care at Imam Reza Clinic and Rajaei Hospital in Shiraz and are entered into the study after gaining their informed consent. Permutation block randomization will be used. In the control group patients will receive 15 mg of meloxicam daily for 10 days and in the intervention group 2 Elartrit capsules daily for 1 month. The person conducting the questionnaires and the data analyzer will be blinded. Finally, the effect on pain reduction and function improvement will be evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent, having manifestations of osteoarthritis, 40 to 60 years of age, and not having periarticular diseases. Exclusion criteria: certain systemic diseases, use of certain drugs, drug hypersensitivity, pregnancy or lactation, severe obesity, neural damage, neuropathy or radiculopathy, severe knee arthritis, history of knee fracture, trauma, joint replacement or injection, and inability to complete questionnaires.
Intervention groups
Treatment in the control group includes 15 mg of meloxicam daily for 15 days. Treatment in the intervention group includes 2 Elartrit ( Elaeagnus angustifolia extract) capsules daily for 1 month. Patients in both groups will be educated on lifestyle modifications and exercises suitable for knee pain, and all patients will be given omeprazole to take if needed.
Main outcome variables
Degree of pain and function of patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220502054724N1
Registration date: 2022-07-11, 1401/04/20
Registration timing: prospective

Last update: 2022-07-11, 1401/04/20
Update count: 0
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
Mohammad Haghighat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 1467
Email address
mammadht@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of Elaeagnus angustifolia extract (Elartrit) drug in comparison with meloxicam on pain relief and functional improvement of patients with knee osteoarthritis referred to physical medicine and rehabilitation clinics of Shiraz University of Medical Sciences
Public title
Effect of Elartrit in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Filling and signing the consent form Having pain and other clinical manifestations of knee osteoarthritis in the last month Being between 40 to 60 years old Not having any periarticular disease around the joint in question
Exclusion criteria:
High grade arthritis according to radiology Presence of diabetes mellitus Presence of rheumatologic and collagen vascular diseases such as gout and lupus Presence of concomitant radiculopathy Presence of neural damage and neuropathy Presence of brucellosis Presence of any malignancy Presence of a history of significant liver disease Presence of a history of significant liver disease Presence of a history of significant kidney disease Presence of a history of significant cardiac disease Presence of a history of significant pulmonary disease A body mass index greater than 42 Presence of a history of knee joint replacement in the knee being studied Presence of a history of trauma or fracture in the knee being studied Presence of bleeding disorders Presence of an inability to communicate and to complete questionnaires Presence of a history of allergic or hypersensitivity reaction to the drugs being used Presence of a history of injections in the last 3 months within or around the joint being studied Presence of a state of pregnancy or lactation Patients taking anticoagulant medications Presence of a history of gastrointestinal and stomach disease Use of warfarin and ticlopidine
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation block randomization will be used for random allocation, in which "A" represents the patient receiving meloxicam and "B" represents the patient receiving Elartrit. In this method there will be a total of 6 possible quadruple permutations. In the next step, using a random number, codes 0 to 9 will be assigned to each of these permutations (i.e. ABAB Code 0, BABA Code 1, AABB Code 2, BBAA Code 3, BAAB Code 4, and ABBA Code 5 to 9). In this way, the required random list of 60, including 15 blocks of 4 (4 x 15 = 60 total number of samples) will be obtained and the order of assignment to each sample will be determined. The method of using the random number table will be such that the starting point will be selected randomly and 15 numbers from 0 to 9 will be selected randomly (column-wise or row-wise) and the permutation assigned to each of the numbers will be determined. The permutations will be placed side by side from left to right, and the allocation of the total of 60 people to groups A and B (30 people in each group) will be determined. Thus, two lists of 30 people, consisting of the groups A and B, will be obtained randomly. For concealment purposes, this random sequencing method will be given to another person who is not aware of the research process, and the questionnaires will be completed by this person who is unaware of the group divisions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: in this study, it is not possible to blind the participants because the participants are aware of their intervention (their drug). Clinical care giver: the caregiver is instructed on how to conduct the questionnaire and is not aware of the patient’s intervention. Researcher: in this study, it is not possible to blind the researcher as he is aware of the intervention used in each case. The outcome assessor: the completed questionnaires are given to an individual who is not aware of the intervention performed and he/she is asked to determine the degree of pain relief and improvement of function according to the questionnaires. Data analyzer: the questionnaires are finally given to an individual to review the information. This individual will not be aware of any of the steps of the study nor of the classification of the interventions performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Research Department of the School of Medicine, Building No. 3, School of Medicine, Imam Hossein square,
City
Shiraz
Province
Fars
Postal code
۷۱۳۴۸۴۵۷۹۴
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.SUMS.MED.REC.1401.104

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified

Primary outcomes

1

Description
Pain caused by knee osteoarthritis
Timepoint
Before starting the intervention; 2, 4, and 8 weeks later
Method of measurement
Visual analog scale; Western Ontario and McMaster Universities Arthritis Index; Oxford knee scale; Patient satisfaction

Secondary outcomes

1

Description
Degree of knee dysfunction
Timepoint
Before starting the intervention; 2, 4, and 8 weeks later
Method of measurement
Western Ontario and McMaster Universities Arthritis Index; Oxford knee scale; Patient satisfaction

Intervention groups

1

Description
Control group: Treatment in this group includes taking 15 mg of meloxicam daily for 15 days, as well as educating patients in the clinic on lifestyle modifications and exercises suitable for knee pain. In addition, all patients will be given omeprazole to take if required daily in the morning in fasting state.
Category
Treatment - Drugs

2

Description
Intervention group:Treatment in this group includes taking 2 Elartrit capsules daily for 1 month, as well as educating patients in the clinic on lifestyle modifications and exercises suitable for knee pain. In addition, all patients will be given omeprazole to take if required daily in the morning in fasting state.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam reza rehabilitation clinic
Full name of responsible person
Mani Ramzi
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7700
Email
motahari@sums.ac.ir

2

Recruitment center
Name of recruitment center
Rajaee hospital
Full name of responsible person
Amirreza Mesbahi
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
Rajaeehospital@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
In front of Maaref school; Khalili Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
Info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Haghighat
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Flat 6 Ahoora Building, 36/1 Ghasrodasht Ave.
City
Shiraz
Province
Fars
Postal code
7193687936
Phone
+98 71 3626 1467
Email
mammadht@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Haghighat
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Flat 6 Ahoora Building, 36/1 Ghasrodasht Ave.
City
Shiraz
Province
Fars
Postal code
7193687936
Phone
+98 71 3626 1467
Email
mammadht@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Haghighat
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Flat 6 Ahoora Building, 36/1 Ghasrodasht Ave.
City
Shiraz
Province
Fars
Postal code
7193687936
Phone
+98 71 3626 1467
Email
mammdht@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
All available data are shareable after rendering individuals unidentifiable.
When the data will become available and for how long
Access period begins one year after publishing of results.
To whom data/document is available
Everyone can access this information.
Under which criteria data/document could be used
If the information in this study helps to improve the science process.
From where data/document is obtainable
Mohammad Haghighat, mammadht@gmail.com
What processes are involved for a request to access data/document
Upon receiving such a request, all authors of the study will be consulted and all information will be sent within a maximum of three weeks if permitted by all authors.
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