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IRCT20221101056363N1 IRCT 2022-11-22 Mashhad University of Medical Sciences The effect of injectable and sustained-release pharmaceutical form of celecoxib in the treatment of knee osteoarthritis patients Clinical trial of hybrid thermosensitive hydrogel based on hyaluronic acid containing celecoxib for knee osteoarthritis patients 2023-01-21 anticipated 84 Complete https://irct.ir/trial/66623 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the randomization method is the “permuted block randomization” method. with the following steps: 1- First, we fill the paper for the two treatments A and B with the number of sample size (84 patients) So that we assign 42 patients to A and another 42 patients to B. 2- We put the papers into the lottery bottle and mix thoroughly. We place each one randomly in an envelope. 3- Then patients will be randomly assigned to A and B groups through sealed envelopes. 3 Knee osteoarthritis. Intervention 1: Intervention group: Patients with primary OA of the knee, who after checking the entry and exit criteria and signing the consent form, were randomly injected with temperature-dependent hydrogel containing celecoxib.The surgeon will repeat the injection at week 0, 2 and 4, 2 cc each time for each patient (6 cc in total). Intervention 2: Control group: Patients with primary OA of the knee, who after checking the entry and exit criteria and signing the consent form, were randomly injected with Hyalgan gel. The surgeon will repeat the injection at week 0, 2 and 4, 2 cc each time for each patient (6 cc in total). Yes - There is a plan to make this available What will be shared: All data including range of motion tests and blood tests will be shared. When: The access starts 2 months after the publication of the article and the patent.برای To whom: All academic and scientific researchers as well as industry are allowed access. Conditions: All the analyzes will be done by us and will be provided to the researchers just to clarify the data. Where to obtain: Refer to the person in charge of the project and Mashhad University of Medical Sciences. How to obtain: An email will be sent to the university and the project manager. Comments:

public Mona Alibolandi

Vakil Abad Boulevard, University Campus, Faculty of Pharmacy

Mashhad Iran (Islamic Republic of) 91775-1365 009851 3801205 alibolandim@mums.ac.ir Mashhad University of Medical Sciences scientific Mona Alibolandi

Vakil Abad Boulevard, University Campus, Faculty of Pharmacy

Mashhad Iran (Islamic Republic of) 91775-1365 009851 3801205 alibolandim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Primary one-sided osteoarthritis of the knee that has been at least 6 months since it became symptomatic (painful) and aggravated by weight bearing and has not responded properly to conservative treatment. Radiographic arthrosis stage 1, 2 and 3 of Kellgren Lawrence classification (KLS) Signing the consent form and complete and voluntary willingness to participate in the study 45 years 80 years Both Any history of trauma (fracture), surgery and tumor in the knee and lower limb of the same side Clinically obvious alignment disorder Any history of invasive procedure, injection or infection in the desired knee during the last 6 months Any blood disorder History or history of autoimmune disease or being treated with immunosuppressors and non-removable corticosteroids Patients with secondary osteoarthritis Proven liver and kidney disorders Irrevocable consumption of oral or topical painkillers Cognitive impairments and the inability to walk without a walker or the help of others CVA and similar problemsInsulin-dependent diabetic patients Patients with spine disorders and radicular pain to the lower limbs M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Patients with primary OA of the knee, who after checking the entry and exit criteria and signing the consent form, were randomly injected with temperature-dependent hydrogel containing celecoxib.The surgeon will repeat the injection at week 0, 2 and 4, 2 cc each time for each patient (6 cc in total). Control group: Patients with primary OA of the knee, who after checking the entry and exit criteria and signing the consent form, were randomly injected with Hyalgan gel. The surgeon will repeat the injection at week 0, 2 and 4, 2 cc each time for each patient (6 cc in total). Evaluation of the parameters related to the immune system including the level of IL-10, TNF-a, IL-6, TGF-beta1). Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Commercial lab kits. Liver tests including the serum level of ALT and AST. Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Commercial kits. BUN and creatinine. Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Commercial kits. Range of motion of the joint (goniometer and degree). Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: goniometer and degree. The sitting and standing test (number). Timepoint: It will be performed at the beginning, second week and fourth weeks. Method of measurement: Physical examination. Mashhad University of Medical Sciences Approved 2022-08-13 Ethics committee of Mashhad University of Medical Sciences Vakyl Abad Boulevard, Mashhad University of Medical Sciences, School of Pharmacy Mashhad Razavi Khorasan Iran (Islamic Republic of)