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IRCT2017103037093N1 IRCT 2017-11-20 Vice chancellor for research, Shahrekord University of Medical Sciences Chicory gel effect on the treatment of osteoarthritis comparsion of the effects of 3% Cichorium intybus L. hydroalcoholic extract gel vs diclofenac gel in the treatment of patients with primary monoarticular knee osteoarthritis who are taking celecoxib. 2017-12-03 anticipated 150 Complete https://irct.ir/trial/27533 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was done using random numbers table and statistical software, Blinding description: The gel tubes were prepared by the pharmacist and were labeled A, B, and C. None of the patients and researchers knew about their content. 3 Knee osteoarthritis. Intervention 1: Negative control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use the gel containing the base of the gel (placebo) three times a day each time for 3 to 5 minutes for 6 Weeks over the involved area. Intervention 2: Positive control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day, and use 1% diclofenac gel three times a day each time for 3 to 5 minutes for 6 weeks over the involved area. Intervention 3: Intervention group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use 3% chicory gel three times a day for 3 to 5 minutes for 6 weeks over the involved area. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared. When: Start the access period 4 months after publishing the results To whom: Researchers working in academia Conditions: Use data to complete clinical trial studies Where to obtain: Kashani Hospital in Shahrekord, dehghan_mortaza@yahoo.com How to obtain: after the investigation of resercher request and presentation of required documents will be accessible. Comments:
public Morteza Dehghan
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 dehghan_mortaza@yahoo.com Shahrekord University of Medical Sciences scientific Morteza Dehghan
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 dehghan_mortaza@yahoo.com Shahrekord University of Medical Sciences Iran (Islamic Republic of) age of 40-80 years weight of 50-80 kgs primary osteoarthritis in one knee, confirmed by radiological criteria in knee graphy secondary osteoarthritis or suspecting to it lack of history of cognitive impairment lack of Liver,kidney or any other underlying disease having no history of allergies 40 years 80 years Both primary osteoarthritis in both knees history of allergy to any form of anti-inflammatory drugs skin diseases,infection or ulcers at the site of topical use of the drug use of other topical drugs at the place of use of the drug use of aromatase inhibitors the oral administration of other analgesics and other compounds effective in the treatment of osteoarthritis up to 10 days before the start of the study congenital joint diseases pregnancy lack of cooperation and desire of the individual during the study to continue the company creation of any Sensitivity or any problem during the intervention M17.1 Other primary gonarthrosis Placebo Treatment - Drugs Treatment - Drugs Negative control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use the gel containing the base of the gel (placebo) three times a day each time for 3 to 5 minutes for 6 Weeks over the involved area. Positive control group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day, and use 1% diclofenac gel three times a day each time for 3 to 5 minutes for 6 weeks over the involved area. Intervention group: Patients with primary monoarticular osteoarthritis of knee joint who take 200 mg celecoxib tablets once a day and use 3% chicory gel three times a day for 3 to 5 minutes for 6 weeks over the involved area. Knee pain. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Western Ontario & McMaster Universities Osteoarthritis Index & Visual Analogue Scale questionnaire. Daytime stiffness. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Western Ontario & McMaster Universities Osteoarthritis Index questionnaire. Morning stiffness. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Western Ontario & McMaster Universities Osteoarthritis Index questionnaire. Physical performance. Timepoint: Before intervention, 6 weeks after intervention. Method of measurement: Western Ontario & McMaster Universities Osteoarthritis Index questionnaire. Skin allergy. Timepoint: Six weeks after the intervention. Method of measurement: Observation and examination. Vice chancellor for research, Shahrekord University of Medical Sciences Approved 2017-10-29 Ethics Committee of Shahrekord University of Medical Sciences Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)