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IRCT20150721023282N14 IRCT 2020-09-20 Fardis pharmaceutical company Effect of Boswellia in treatment of knee Osteoarthritis Evaluation of the effectiveness of frankincense oily lotion containing boswellic acid enriched extract in the treatment of knee osteoarthritis symptoms: a randomized placebo-controlled clinical trial 2020-07-18 anticipated 50 Complete https://irct.ir/trial/50149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization will be performed using random number table, Randomization description: In this study Block Randomization will be used. For this purpose, quadruple blocks will be used, Blinding description: The drug and placebo lotions will be packaged in completely similar containers and the prescribing physician, data collecting person and patient will be blinded to the content of containers. N/A Knee osteoarthritis. Intervention 1: Intervention group: Oily lotion of frankincense extract containing 65% boswellic acid (manufactured by Fardis pharmaceutical company), 3 times daily for 4 weeks. Intervention 2: Control group: Placebo lotion (manufactured by Fardis pharmaceutical company), 3 times daily for 4 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 There is no more data.
public Rasool Soltani
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar-Jerib Avenue
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences scientific Rasool Soltani
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 7067 soltani@pharm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) age of 40 - 80 years Osteoarthritis of at least one knee for at least 3 months based on the diagnostic criteria of American College of Rheumatology (ACR) Pain score > 4 mm based on the Visual Analogue Scale (VAS) Grade 2 or 3 of Kellgren-Lawrence scale in knee radiography within the past 3 months 40 years 80 years Both Use of intra-articular glucocorticoids within the past 3 months Use of intra-articular sodium hyaluronate within the past 6 months Use of systemic glucocorticoids (either oral or parenteral) within the past 14 days Having other osteoarticular disorders (e.g., rheumatoid arthritis and gout) Skin disorder in knee region Sensitivity to prescribed topical formulations Knee arthroscopy within the past 3 months Illiteracy Unable to answer the questions Pregnancy Lactation Other prim M17.1 Treatment - Drugs Treatment - Drugs Intervention group: Oily lotion of frankincense extract containing 65% boswellic acid (manufactured by Fardis pharmaceutical company), 3 times daily for 4 weeks Control group: Placebo lotion (manufactured by Fardis pharmaceutical company), 3 times daily for 4 weeks WOMAC Index. Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: Questionnaire. Visual analogue scale (VAS). Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: scoring on the scale. Patient global assessment (PGA). Timepoint: Before the intervention and 4 weeks after the intervention. Method of measurement: scoring on the scale. Fardis pharmaceutical company Approved 2020-07-15 Ethics committee of Isfahan University of Medical Sciences Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan Isfahan Isfehan Iran (Islamic Republic of)