A Prospective, Multi-centric, Randomized, Double-Blind Study to Compare the Safety and Efficacy of CurQfenÂ® plus Glucosamine, Chondroitin plus Glucosamine and CurQfen in Mild to Moderate Knee Osteoarthritis.

Akay Flavours and Aromatics Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1Subject with OA (Class I â?? III), according to Kellgren and Lawrence system and confirmed by X ray, who have been completely withdrawn from their previous analgesics or anti-inflammatory medications or have been newly diagnosed with mild to moderate primary knee OA, and who are not currently taking any analgesics or anti-inflammatory medications
•2Subjects willing to perform walking test and ready to fill up the questionnaires
•3Females of child bearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening
•4Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study

•1Subjects with OA secondary to a known disorder: Rheumatoid arthritis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, any history of fracture involving the study joint, or any other type of arthritis.
•2Subjects who had surgery, or arthroscopy within three months prior to inclusion
•3Subjects who have been administered hyaluronic acid injections within six months prior to inclusion
•4Subjects with severe bone or joint deformation or condition
•5Subjects who have used glucosamine and/or chondroitin containing compounds within seven days prior to the screening visit
•6Subjects with a body mass index (BMI) >= 28 kg/m2
•7Subjects who have used medications with matrix metalloproteinases-inhibitory properties (e.g. tetracycline or structurally related compounds) or took corticosteroids (systemic, >10 days duration) within 28 days of Screening Visit.
•8Subjects with a known allergy to herbal products and nonsteroidal anti-inflammatory drugs
•9Subjects with autoimmune complications
•10Subjects with any oncological condition
•11History of cardiovascular, type 2 diabetes mellitus, pulmonary, hepatic and renal problems
•12Subjects with abnormal biochemical or haematological values at screening
•13Any condition that in opinion of the Investigator, does not justify the subjects participation in the study.

发起方

Akay Flavours and Aromatics Private Limited