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IRCT20221218056851N2 IRCT 2023-12-03 Arak University of Medical Sciences Effect of local cannabinoid administration on knee osteoarthritis Effect of local cannabinoid administration on knee osteoarthritis: A randomized triple-blind placebo based clinical trial 2023-10-23 anticipated 50 Complete https://irct.ir/trial/73661 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To divide the patients into two groups A and B, the Restricted Randomization method was used according to the Random Allocation Rule. In this method, which is done using the random allocation software, 50 patients from They are numbered up to 50 and are divided into two groups A and B by the software. One group (group A) receives the placebo and group B receives the cream containing cannabinoids, Blinding description: The study is a three-blind study, a statistician who randomly places the patients in two groups receiving placebo and convert, without knowing the contents of the creams, he provides them to the patients. The researchers will be unaware of the grouping as well as the drugs that each group receives. Patients will also be unaware of the medicine they receive. In addition, the cream that is used as a placebo is completely similar to the cream containing cannabinoids in terms of appearance (color, smell, concentration, etc.) and packaging, and is indistinguishable for patients. Also, the researchers are not aware of how the drugs are distributed among the patients. 2-3 Knee osteoarthritis. Intervention 1: Intervention group: Canvert cream is produced according to the order of Alasht Pharmed Company in Mon Rogin Company in Iran, Alborz Province and contains cannabidiol. How to use the cream, as mentioned in the cream brochure, put a sufficient amount of the product (a knuckle) on the skin of the desired area (knee) and massage it with your hand until it is completely absorbed. Patients use this cream twice a day for 12 weeks. Intervention 2: Control group: In the control group, a placebo is used. The placebo is also produced by Alasht Pharmed Company in Monrogin Company in Iran, Alborz Province, and has the same ingredients as Convert Cream, but does not contain cannabidiol. How to use the cream, as mentioned in the cream brochure, put a sufficient amount of the product (a knuckle) on the skin of the desired area (knee) and massage it with your hand until it is completely absorbed. Patients use this cream twice a day for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the incompleteness of the study, no decision has been made to publish it.
public Dr Mona Hamedi Tabar
Arak Univercity of Medical Science, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 hamedimona.1996@gmail.com Arak University of Medical Sciences scientific Dr Mona Hamedi Tabar
Arak Univercity of Medical Science, Arak
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3639 hamedimona.1996@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age referred to the orthopedic clinic of Valiasr Arak Hospital with complaints of knee osteoarthritis pain. 18 years no limit Both M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Canvert cream is produced according to the order of Alasht Pharmed Company in Mon Rogin Company in Iran, Alborz Province and contains cannabidiol. How to use the cream, as mentioned in the cream brochure, put a sufficient amount of the product (a knuckle) on the skin of the desired area (knee) and massage it with your hand until it is completely absorbed. Patients use this cream twice a day for 12 weeks. Control group: In the control group, a placebo is used. The placebo is also produced by Alasht Pharmed Company in Monrogin Company in Iran, Alborz Province, and has the same ingredients as Convert Cream, but does not contain cannabidiol. How to use the cream, as mentioned in the cream brochure, put a sufficient amount of the product (a knuckle) on the skin of the desired area (knee) and massage it with your hand until it is completely absorbed. Patients use this cream twice a day for 12 weeks Pain. Timepoint: immediately and 12 weeks after. Method of measurement: WOMAC (Western ontario and mcmaster universities index) questionnaire. Joint stiffness. Timepoint: immediately and 12 weeks after. Method of measurement: WOMAC questionnaire. Limitation of movement. Timepoint: immediately and 12 weeks after. Method of measurement: WOMAC questionnaire. Arak University of Medical Sciences Approved 2023-10-01 Research ethics committees of Arak University of Medical Sciences Arak Univercity of Medical Science, Arak Arak Markazi Iran (Islamic Republic of)