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IRCT20200522047538N2 IRCT 2024-01-22 Mashhad University of Medical Sciences Evaluation of the effectiveness of metformin in WOMAC index of overweight knee osteoarthritis patients Evaluation of the effectiveness of metformin in WOMAC index of overweight knee osteoarthritis patients 2024-02-20 anticipated 88 Complete https://irct.ir/trial/74954 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method will be used to generate a sequence of random numbers. In this method, 40 blocks of size 4 and 25 blocks of size 2 are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks of size two are 1:AB, 2:BA and the list of blocks of size four are: 1:AABB, 2:ABBA, 3:BBAA, 4:BAAB, 5:BABA, 6:ABAB. To select blocks of size 2, 25 numbers are randomly selected from the table of random numbers, then if this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 40 numbers between 1 and 6 are randomly selected from the table of random numbers, then if this number is 1, the first block is size 4, and if the selected number is 2, then the second block and so on for other blocks. are selected Allocation Concealment method: The sequence obtained from the randomization method will be recorded on separate sheets, then the obtained sheets will be placed in non-transparent envelopes and the specified treatment will be applied to the patients in the order of arrival of the patients. ​, Blinding description: All patients and doctors evaluating the interventions designed in the study or the outcomes after the intervention (rheumatology assistant and rheumatology subspecialist) will not know about the group in which the patient is examined. All interventions in both groups will be designed similarly and the procedure will be the same on all samples in all groups. The drugs used will also be supplied in the same form and packaging so that it is not possible to identify the study group during the study process. 3 Osteoarthritis. Intervention 1: Intervention group: metformin tablets (ingredients: microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, and metformin hydrochloride) Kushan Pharmed company - 500 mg per day with food -during 4 months - patient educate about gastrointestinal complications and Improvement of symptoms by continuing to take the drug. Intervention 2: Control group: Placebo pill (ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate) formulated by the Mashhad Faculty of Pharmacy, one pill per day with food for 4 months. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: Access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions Conditions: There are no special conditions. Where to obtain: Dr. Maryam Kiani Phone number :00989113778569 Email: kiani.m94@gmail.com How to obtain: The applicant should provide his / her study file and the purpose of receiving the data in the form of an email with his / her research file (research plan), then after 3 months the file will be provided to the person Comments:
public Dr.Maryam Kiani
No.291,19th daneshagh, Daneshgah Ave, Mashhad
Mashhad Iran (Islamic Republic of) 9138914631 +98 911 377 8569 kiani.m94@gmail.com Mashhad University of Medical Sciences scientific Zahra Mirfeizi
Rheumatology Ward, Emam Reza hospital, Emam Reza Sq
Mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 915 156 2868 mirfeiziz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients who, based on the radiography and ACR criteria, have knee osteoarthritis grades 2 & 3 according to the Kellgren and Lawrence criteria (Kellgren and Lawrence grade 2, the presence of osteophytes and joint space narrowing & grade 3 confirming the presence of more numbers of sclerosis and osteophyte). 50 to 75 years olds Man or woman BMI body mass index (≥24 kg/m2) VAS Knee pain score≥ 2 on 10 Primary Osteoarthritis (not secondary OA due to trauma or inflammatory arthritis) The person is willing and able to follow the study instructions and go to the clinic for a visit No history of performing knee arthroscopy and injecting corticosteroids in the knee within less than 6 months from the beginning of the study No allergy to any of the compounds used in the study No history of severe trauma in the knee area No history of other rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis and others No active malignancy, cancer or other life-destructive diseases and Type 1 or type 2 diabetes mellitus, hypoxic conditions (corpulmonary-congestive heart failure-acute MI-peripheral artery disease), uncontrolled high blood pressure No Clinical manifestation of liver dysfunction or elevated alanine aminotransferase/aspartate ami- notransferase levels exceeding 2 times the upper limit of normal values GFR glomerular filtration rate higher than ml/min/1.73m2-60 No history of systemic corticosteroids using Not using of alcoholic substances No history of Conditions affecting the absorption of oral drugs (e.g., post gastrectomy and malabsorption syndrome) No history of using metformin in the last 30 days 50 years 75 years Both Injecting of corticosteroids in the knee within the study Estimated glomerular filtration rate of less than 60 ml/min/1.73 m2; Allergic to metformin hydrochloride; Severe knee trauma during study M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: metformin tablets (ingredients: microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, and metformin hydrochloride) Kushan Pharmed company - 500 mg per day with food -during 4 months - patient educate about gastrointestinal complications and Improvement of symptoms by continuing to take the drug. Control group: Placebo pill (ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate) formulated by the Mashhad Faculty of Pharmacy, one pill per day with food for 4 months. WOMAC INDEX of osteoarthritis. Timepoint: evaluation of WOMAC index before the study and 4 month later. Method of measurement: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. The Visual Analogue Scale (VAS) pain score. Timepoint: before the start of the intervention and four consecutive month after the start of the intervention. Method of measurement: The Visual Analogue Scale (VAS) pain score 0-10. Mashhad University of Medical Sciences Approved 2023-09-18 research ethics committee of imam Reza hospital Educational Research and treatment Center-Mashhad U Imam Reza (AS) Educational Research and Treatment Center, Ibn Sina Street, Imam Reza (AS) Hospital Square, Razavi Khorasan Mashhad Razavi Khorasan Iran (Islamic Republic of)