An Exploratory, Randomized, Open Label, Controlled, Cross over Study to Investigate the Efficacy and Tolerability of ActiTape in Patients with Pain in Knee Joint due to Mild to Moderate Osteoarthritis

utriworks Limited0 个研究点目标入组 14 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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•1.Ambulatory adult patients of either sex aged 30-65 years.
•2.Patients with moderate OA of the knee, which can be clinically, categorized as ARA functional Class II and III and with radiological confirmation of Kellgren Lawrence Grade II and III.
•3.Patientâ??s functional assessment of overall pain score should be >= 50 mm on a 100 mm VAS for pain at baseline visit.
•4.Patients receiving a stable dose of oral calcium or chondrogenic supplements for at least past 1 month and/or a stable dose of NSAIDs for the past 1 week will be eligible for inclusion

•1.Patients of any form of arthritis other than osteoarthritis.
•2.Arthroscopy of either knee in the past year.
•3.Administration of intra-articular or oral steroids in the past 3 month or intra articular hyaluronic acid in the last 9 months or parenteral use of NSAIDs.
•4.Patients requiring immediate surgery for knee.
•5.Pregnant / lactating women and women who are planning to get pregnant
•6.Recent ( 3 months) participation in a clinical study
•7.History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections
•8.Patients with a risk of Deep Vein Thrombosis (DVT) as depicted by a score of >=3 on the Wellâ??s questionnaire
•9.Patients with localized trauma to the lower limb
•10.Dermatological conditions affecting the lower limb
•11.History of skin irritation on application of bandages/tapes
•12.A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms
•13.Patients otherwise judged by the investigator to be inappropriate for inclusion in the study

发起方

utriworks Limited