Clinical evaluation of anti-inflammatory and analgesic activities of AQUA-TURMÂ® in Subjects Suffering from Osteoarthritis of Knee(s) â?? A Randomized, Double Blind, Placebo Controlled, Multi-centre, Comparative, interventional, Prospective Study - NI

odaat Pharma0 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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•1.History of knee pain due to osteoarthritis requiring use of NSAIDs, Acetaminophen, or another analgesic agent.
•2.OA confirmed by radiographs and diagnosed according to ACR diagnostic criteria (clinical+ radiological) for the osteoarthritis of the knee(s)
•3.Knee joint(s) pain greater than or equal to 40 on Visual Analogue Scale (VAS).

•1.Subjects with rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
•2.Subjects with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
•3.Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study
•4. Subjects with signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and or baseline visits
•5.Subjects using systemic corticosteroids within 2 months of screening, or intraarticular visco supplementation within the past 3 months
•6. Subjects with any other investigational drug within 1 month prior to randomization;
•7. Subjects with uncontrolled diabetes mellitus and hypertension
•8. Subjects with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure
•9. Pregnant and lactating women
•10. Subjects with significant abnormal laboratory parameters
•11. Known hypersensitivity to any of the ingredients of AQUA-TURM
•12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of the protocol

发起方

odaat Pharma