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IRCT20220812055668N1 IRCT 2022-11-16 Shiraz University of Medical Sciences The effect of a topical product prepared from mustard seed oil in patients with knee osteoarthritis Evaluation the effect of a topical product prepared from mustard seed oil in controlling pain and improving the performance of patients with knee osteoarthritis, a double-blind randomized controlled clinical trial 2022-10-02 anticipated 30 Complete https://irct.ir/trial/65432 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 30 patients are randomly divided between two groups of 15 people in a double-blind clinical trial using the block randomization method .This study is a double blind randomized controlled clinical trial. Patients in both the control group and the drug group are entered based on a random number table. For the control group, a topical cream without medicine (cold cream) is used. The doctor and the patient are not informed about the type of cream (containing medicine or without medicine). Determining the sample size and randomization was done with a computer statistical program. The minimum sample size in each group is 15 people, Blinding description: The study will be conducted in a double-blind manner and only the evaluator will know the results and code of the drug or placebo group. Creams of drug and drug group are completely similar in appearance. The drug and placebo groups will be separated from each other by receiving the code. 3 knee osteoarthritis. Intervention 1: Intervention group: Patients who underwent intra-articular injection of Hyaluronic Acid (Hyaluronic Acid Sodium salt 2%) called vijoint one (in the form of a ready-to-inject 60mg/3ml sodium hyaluronate cross-link syringe, manufactured by Apharm, Italy) were included in the study. One week after intra-articular injection of hyaluronic acid, topical medicine (cream prepared from mustard oil) is started to be used for patients. The studied topical product is used twice a day for 1 month. Patients are evaluated at intervals of 4 weeks and 3 months. During the period of examination of the patients, the painkillers are completely identical, including acetaminophen 500 mg, 2 times a day at the time of pain. Patients whose pain does not improve with this amount of medicine, use diclofenac 100 mg tablets. Intervention 2: Control group: In this group, 15 patients use placebo, which is the same cold cream, for 1 month and twice a day in the place of pain (knee). It should be noted that the placebo contains all the components of the original cream except the active ingredient (mustard seed oil). Yes - There is a plan to make this available What will be shared: The overall results of the study will be published. When: After completing the study To whom: Scientific centers Conditions: Conducting scientific studies Where to obtain: ZARM@SUMS.AC.IR How to obtain: send mail Comments:
public Mohammad Mehdi Zarshenas
Faculty of Pharmacy, Shiraz
Shiraz Iran (Islamic Republic of) 713451583 +98 917 117 3491 zarm@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammad Mehdi Zarshenas
Faculty of pharmacy, Shiraz
Shiraz Iran (Islamic Republic of) 7146864685 +98 71 3242 6122 mmzarshenas@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The study is conducted on patients referred to the pain clinic of Imam Reza (AS) Shiraz With the initial complaint of "knee pain" which has been confirmed as "osteoarthritis of the knee joint" in radiological examination and imaging The age range of patients is between 40 and 80 years Patients with ASA class I, II are included in the study The grade of knee abrasion should be grade II-III based on radiological imaging 40 years 80 years Both Patients with the following underlying diseases are excluded from the study diabetes Connective tissue diseases Peripheral vascular diseases Alzheimer All kinds of diseases and movement disorders of the lower limbs Psychiatric diseases M17 Osteoarthritis of knee Treatment - Drugs Placebo Intervention group: Patients who underwent intra-articular injection of Hyaluronic Acid (Hyaluronic Acid Sodium salt 2%) called vijoint one (in the form of a ready-to-inject 60mg/3ml sodium hyaluronate cross-link syringe, manufactured by Apharm, Italy) were included in the study. One week after intra-articular injection of hyaluronic acid, topical medicine (cream prepared from mustard oil) is started to be used for patients. The studied topical product is used twice a day for 1 month. Patients are evaluated at intervals of 4 weeks and 3 months. During the period of examination of the patients, the painkillers are completely identical, including acetaminophen 500 mg, 2 times a day at the time of pain. Patients whose pain does not improve with this amount of medicine, use diclofenac 100 mg tablets. Control group: In this group, 15 patients use placebo, which is the same cold cream, for 1 month and twice a day in the place of pain (knee). It should be noted that the placebo contains all the components of the original cream except the active ingredient (mustard seed oil) Knee pain. Timepoint: Before the intervention, 4 weeks and 12 weeks after starting to use the topical product of mustard seed oil. Method of measurement: Changes in scores of VAS and WOMAC questionnaires. Joint dryness. Timepoint: Before the intervention, 4 weeks and 12 weeks after starting to use the topical product of mustard seed oil. Method of measurement: Changes in WOMAC questionnaire scores. Patient functionality. Timepoint: Before the intervention, 4 weeks and 12 weeks after starting to use the topical product of mustard seed oil. Method of measurement: Changes in WOMAC questionnaire scores. Shiraz University of Medical Sciences Approved 2022-07-17 Ethics committee of Shiraz University of Medical Sciences University Research Ethics Committee, 7th Floor, Shiraz University of Medical Sciences, Central Building, Zand ST Shiraz Fars Iran (Islamic Republic of)