CTRI/2021/08/035416
Completed
Phase 2
Clinical evaluation of anti-inflammatory and analgesic activities of AQUA-TURM® in Subjects Suffering from Osteoarthritis of Knee(s) â?? A Randomized, Double Blind, Placebo Controlled, Multi-centre, Comparative, interventional, Prospective Study - NI
odaat Pharma0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- odaat Pharma
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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