CTRI/2015/09/006177
Completed
Phase 2
A clinical study to evaluate efficacy and safety of AHPL/AYTAB/0313 in subjects suffering from osteoarthritis of knee(s) - NI
Ari Healthcare Pvt Ltd0 sites48 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ari Healthcare Pvt Ltd
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject willing to participate, who have read, understood and signed informed consent form
- •2\.Subject with history of knee pain due to osteoarthritis requiring use of NSAIDs acetaminophen, or another analgesic agent on a regular basis (greater than or equal to 3 days per week) for at least 6 months before the screening visit.
- •3\.OA confirmed by radiographs and diagnosed according to ACR diagnostic criteria (clinical and radiological) for the OA of the knee.
- •4\.Subjects are willing to make all required study visits
- •5\.Subjects are willing to follow study instructions given by the investigator
Exclusion Criteria
- •1\.Subjects refused to give their informed consent
- •2\.Subjects with rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
- •3\.Subjects with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
- •4\.Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study
- •5\.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
- •6\.Subjects using systemic corticosteroids within 2 months of screening, or intraarticular visco\-supplementation within the past 3 months
- •7\.Subjects with any other investigational drug within 1 month prior to randomization;
- •8\.Subjects having diabetes mellitus, tuberculosis, HIV, ischemic heart disease
- •9\.Subjects with known major medical or surgical disease
- •10\.Pregnant and lactating women
Outcomes
Primary Outcomes
Not specified
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