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IRCT20220502054724N1 IRCT 2022-07-11 Shiraz University of Medical Sciences Effect of Elartrit in knee osteoarthritis 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 2022-07-23 anticipated 60 Complete https://irct.ir/trial/63880 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Knee osteoarthritis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All available data are shareable after rendering individuals unidentifiable. When: Access period begins one year after publishing of results. To whom: Everyone can access this information. Conditions: If the information in this study helps to improve the science process. Where to obtain: Mohammad Haghighat, mammadht@gmail.com How to obtain: 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. Comments:
public Mohammad Haghighat
Flat 6 Ahoora Building, 36/1 Ghasrodasht Ave.
Shiraz Iran (Islamic Republic of) 7193687936 +98 71 3626 1467 mammadht@gmail.com Shiraz University of Medical Sciences scientific Mohammad Haghighat
Flat 6 Ahoora Building, 36/1 Ghasrodasht Ave.
Shiraz Iran (Islamic Republic of) 7193687936 +98 71 3626 1467 mammadht@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 40 years 60 years Both 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 M17.9 Osteoarthritis of knee, unspecified Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. Shiraz University of Medical Sciences Approved 2022-05-23 Ethics committee of Shiraz University of Medical Sciences Research Department of the School of Medicine, Building No. 3, School of Medicine, Imam Hossein square, Shiraz Fars Iran (Islamic Republic of)