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IRCT20150902023864N3 IRCT 2021-02-28 Tehran University of Medical Sciences Effect of Ibuprofen Nanoemulsion Gel on Knee Osteoporosis pain Comparison of the therapeutic effect of 5% ibuprofen nanoemulsion gel and commercial ibuprofen gel on knee osteoarthritis pain 2021-02-19 anticipated 124 Complete https://irct.ir/trial/52942 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed by means of a computer randomization system based on fragmented, balanced randomization. In this method to increase the probability of equal numbers of people in both groups, blocks in the form of: AABB-ABAB-ABBA-BBAA-BABA-BAAB are defined as A containing commercial ibuprofen gel and B nanoemulsion gel containing ibuprofen.From 0 to 5 randomizations will be done using digitally randomized codes. The sequence is constructed in such a way that, with 31 sample volumes, 124 (4⨉31 ) codes will be selected for participants using Excel. Group A: Commercial ibuprofen gel, Group B: Ibuprofen nanoemulsion gel Block sizes: 4 Actual list length: 124 In order to concealment the randomization, the container containing the formulation will be the same in terms of shape, only a code will be written on each package so that the prescriber or the patient will be completely unaware of the contents of the container, Blinding description: Commercial ibuprofen gel will be included in similar packages of nanoemulsion gel containing ibuprofen. The randomized code will be written on the medicine package. However, due to the difference in the smell of these two drugs, we try to prevent patients from being able to compare drugs by conducting separate patient interviews. Based on the random number written on the prescription of the patient, pharmacy officials are asked to deliver the medicine to the patients. The researcher will not know which patient was taking which medication. Also, the treating physician will not be aware of the patient's medication. The patient is requested to deliver the used medicine container to the hospital pharmacy at the next visit and to receive the same number from the pharmacy at the next visit. During the second visit of patients, empty containers of medicines will be collected from the pharmacy every day and stored in a special comedy. The statistical data analyzer will not be able to distinguish between the information obtained from the patients of both groups and the information will be completely blinded to their service. 3 Knee osteoarthritis. Intervention 1: Intervention group 1: Nanoemulsion gel containing 5% ibuprofen; Patients are treated with this formulation for 4 weeks and three times a day in the size of a fingertip (equivalent to 100 mg), which has already been prepared and animal studies have been performed. Intervention 2: Intervention group 2: commercial ibuprofen 5% gel; Patients are treated with a commercial gel available in the pharmacy in the size of a fingertip three times a day, for 4 weeks. Yes - There is a plan to make this available What will be shared: All data potentially can be shared after making participants unidentifiable When: Nearly in a year To whom: All people Conditions: There is no condition Where to obtain: They can email to the researcher How to obtain: We do our best to deliver the data in a month Comments:
public Fariba Esmaeili
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia street, Keshavarz boulevard
Tehran Iran (Islamic Republic of) 1417755469 +98 21 4305 2000 fesmaeili2010@gmail.com Tehran University of Medical Sciences scientific Fariba Esmaeili
No. 87, Third floor, Building No.2, School of Advanced Technologies in Medicine, Italia street, Keshavarz boulevard
Tehran Iran (Islamic Republic of) 1417755469 +98 21 4305 2000 fesmaeili2010@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Unilateral or bilateral knee osteoarthritis with radiographic evidence according to American College of Rheumatology criteria and the International Osteoarthritis Research Society which is diagnosed through physical examination by the physician Having mild to moderate knee osteoarthritis pain Written informed consent to participate in the study 18 years 80 years Both Very severe knee pain Recent lower limb injury or surgery such as repair and joint replacement Inflammatory arthritis Metabolic bone disease Fracture and/or dislocation of knee History of an open wound in the affected knee History of adverse reactions to NSAIDs Diabetes and Lupus disease Corticosteroid injection into the knee within 30 days of intervention Multiple sclerosis (MS) The dermatologic disorder which affected the surrounding skin of the knees Uncontrolled heart failure High blood pressure Chronic renal failure Respiratory diseases Cancer History of alcohol or drug abuse History of neurological disorders affecting sensory, motor or cognitive function M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group 1: Nanoemulsion gel containing 5% ibuprofen; Patients are treated with this formulation for 4 weeks and three times a day in the size of a fingertip (equivalent to 100 mg), which has already been prepared and animal studies have been performed. Intervention group 2: commercial ibuprofen 5% gel; Patients are treated with a commercial gel available in the pharmacy in the size of a fingertip three times a day, for 4 weeks. Pain score based on visual analogue scale and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Timepoint: Patients are assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention for knee pain. Method of measurement: Visual analogue scale on a 10 cm scale and Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. Skin irritation. Timepoint: 24-48 hours in initial use, then two-and four-week visits. Method of measurement: Questions are asked by phone during the first 24-48 hours, so any skin problems are requested and checked by the doctor during each visit. Tehran University of Medical Sciences Approved 2021-01-27 Ethics committee of Tehran University of Medical Sciences Keshavarz Boulevard, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)