Clinical Efficacy and Safety of Yellow Oil Formula 3 and 4 Versus Indomethacin Solution in Symptomatic Treatment of Osteoarthritis of Knee: A Randomized Controlled Study

Department of Pharmacology, Faculty of Medicine, Chiang Mai University0 个研究点目标入组 102 人开始时间: 2017年12月19日最近更新: 2024年8月19日

适应症

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•a) An out patient aged 45 years
•b) Unilateral or bilateral knee OA according to the criteria of ACR knee pain radiographic osteophytes and at least 1 of the following 3 items age 50 years morning stiffness not more than 30 minutes in duration or crepitus on motion The symptoms must be present for at least 3 months
•c) VAS of knee pain between 35 75 point out of 100 after stopping using their usual analgesic or NSAIDs for at least 7 days
•d) Able to walk and
•e) must sign the written consent forms to participate in the study

•a) Underlying inflammatory arthropathy such as rheumatoid arthritis and gout
•b) Hyperuricemia uric acid 9 mg/dL
•c) Plan to undergo surgery in near future
•d) Recent injury in the knee affected by OA
•e) History of intra articular corticosteroid injection within the last 3 months
•f) Hypersensitivity to NSAIDs or herbs used in this study
•g) Use of other NSAIDs or analgesic drugs
•h) Acute OA attack inflammation edema redness warmth
•i) Knee joint effusion
•j) Continuing use of symptomatic slow acting drugs for OA SYSDOA e g glucosamine sulphate chondroitin sulphate diacerein and hyaluronan for less than 4 months or stop using these drugs for less than 6 months
•k) Concomitant skin disease at the application site
•l) Use of another topical product at the application site
•m) Pregnancy or lactation
•n) Malignant tumor or
•o) Clinically significant abnormalities in blood chemistry and hematology
•- Hemoglobin < 9 g/dL
•- White blood cells < 4,000 per cu.mm.
•- Platelets < 100,000 per cu. mm.
•- Alanine aminotransferase ALT aspartate aminotransferase AST or alkaline phosphatase more than 2 times of the upper limit of normal
•- Estimated glomerular filtration rate < 45 mL/min per 1.73 m2 as of the Chronic Kidney Disease Epidemiology Collaboration CKD EPI

发起方

Department of Pharmacology, Faculty of Medicine, Chiang Mai University