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IRCT20200701047978N1 IRCT 2020-08-16 Sabzevar University of Medical Sciences The effect of Alpinia galanga oil on reducing the symptoms of knee osteoarthritis Comparing the effect of topical application of Alpinia galanga (Qost) Oil and Diclofenac jel on symptoms of knee osteoarthritis 2020-08-04 anticipated 158 Complete https://irct.ir/trial/49895 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple, block randomization method will be used for randomization. The individual randomization unit and the randomization tool are sealed drug packages that are completely similar in shape and the patient and the project operator are not aware of the contents of the packages. The allocation of samples in the study will be based on a random sequence provided by the statistical consultant using statistical software, Blinding description: Both painkillers are placed in boxes A (Alpinia Galanga) and B (Diclofenac Jel). Samples are treated with medication packages pre-determined by the study supervisor (supervisor). The drug packages are quite similar in shape and the patient and the executor of the plan are not aware of the contents of the packages. In addition, collecting information, assessing patients and completing forms is done by the project manager and his assistant who are not aware of the contents of the packages. Data analysis is also done by the statistician of the project consultant and the project manager who are not aware of the contents of the drug packages. 3 Knee Osteoarthritis. Intervention 1: Intervention group: Alpinia galanga Oil 5 to 10 drops (amount of active ingredient equal to 80% in sesame oil base made by Tehran School of Pharmacy), twice a day for 28 days topically on the painful joint. Intervention 2: Control group: Diclofenac gel (topical gel 1% 60 g product of Behozan Pharmaceutical Company) twice a day for 28 days topically on the painful joint. 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 There is no more information.
public Fereshteh Ghorat
Headquarters of Sabzevar University of Medical Sciences; Asadabadi street
Sabzavar Iran (Islamic Republic of) 9617213112 +98 51 4401 1000 drghorat@gmail.com Sabzevar University of Medical Sciences scientific Fereshteh Ghorat
Asadabadi St., Central Organization of University of Medical Sciences., Sabzevar Town
Sabzavar Iran (Islamic Republic of) 9617213112 +98 51 4401 1000 drghorat@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) Age of 45 to 70 years old Patients with osteoarthritis according to the American College of Rheumatology Criteria and grade 1 to 3 osteoarthritis according to the Clagren-Lawrence criterion Written consent to enter the study Patient cooperation during the study Possibility of timely and correct use of medicine 45 years 70 years Both Patients with abnormal knee anatomy and joint replacement surgery Patients with knee joint infections Suffering from serious underlying diseases such as liver and kidney disorders, diabetes, etc. Patients with severe skin problems of the knee area Patients with intra-articular injection of steroids within the last three months prior to enrollment Patients with intramuscular steroid injections within the past month before enrollment Patients with known intolerance or allergy to Diclofenac or Alpinia Galanga Blindness and deafness or inability to communicate Taking psychotropic drugs Taking drugs or taking corticosteroids M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Alpinia galanga Oil 5 to 10 drops (amount of active ingredient equal to 80% in sesame oil base made by Tehran School of Pharmacy), twice a day for 28 days topically on the painful joint Control group: Diclofenac gel (topical gel 1% 60 g product of Behozan Pharmaceutical Company) twice a day for 28 days topically on the painful joint Pain. Timepoint: Before the intervention, after 14 and 28 days after the use of Alpinia galanga Oil and diclofenac gel. Method of measurement: WOMAC standard questionnaire. Physical function. Timepoint: Before the intervention, after 14 and 28 days after the use of Alpinia galanga Oil and diclofenac gel. Method of measurement: WOMAC standard questionnaire. Joint dryness. Timepoint: Before the intervention, after 14 and 28 days after the use of Alpinia galanga Oil and diclofenac gel. Method of measurement: WOMAC standard questionnaire. Sabzevar University of Medical Sciences Approved 2020-02-22 Ethics Committee of Sabzevar University of Medical Sciences Headquarters of Sabzevar University of Medical Sciences; Asadabadi street Sabzevar Razavi Khorasan Iran (Islamic Republic of)