A 12-week randomised double blind clinical trial to assess the effectiveness and safety of a herbal formulation on knee pain among patients with osteoarthritis of the knee

ICM Health Research Institute, Western Sydney University0 个研究点目标入组 75 人开始时间: 2019年3月1日最近更新: 2021年6月7日

试验速览

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•1. Male or Female age 40 to 75
•2. Clinical diagnosis of primary OA of the knee in at least one knee joint according to the American College of Rheumatology (ACR) for at least 3 months duration
•3. Demonstration of radiological evidence of OA of the knee on the Kellgren and Lawrence scale Grades I to III
•4. Average daily pain over 7 days to the affected knee on weight bearing activities between 30 to 80mm on a VAS (0 to 100mm) scale before baseline
•5. BMI less than or equal to 35kg/m2
•6. Participants normally active, not bedridden or confined to a wheelchair, able to walk 50m without the use of a walker, crutches or a cane
•7. Participants able to understand and read and write in English

•1.History of underlying inflammatory disease, arthropathy or rheumatoid arthritis or fibrosis where ESR>20 for men and >30 for women.
•2.Gout or pseudogout within the last 3 months, and/or history of gout in the knee joint. Hyperuricaemia (440 micro mol/l) and /or high uric acid levels >380 micro mol/l
•3.History of trauma to the knee affected by OA
•4.Use of anticoagulants, systemic or intra-articular corticosteroid injections within the preceding 3 months; arthroscopy within preceding 3 months.
•5.Hepatic or renal impairment within the last 6 months
•6.Uncontrolled hypertension, congestive heart failure, malignancies, haematological disorders or neurological disorders
•7.Have had major surgery in the past month or major surgery scheduled in the next 3 months
•8.Pregnant or lactating females
•9.Use of other supplements for OA (e.g. chondroitin, glucosamine, curcumin, omega-3 fatty acids)
•10.Use of NSAID’s or analgesics for osteoarthritis including washout period of at least 3 days, including both oral and topical formulations
•11.Disability by law (blindness, deafness, cognitive deficits, mental deficits, physical deficits)
•12.Alcohol intake > 2 standard drinks per day

发起方

ICM Health Research Institute, Western Sydney University