CTRI/2017/06/008790
Completed
Phase 2
An Open Label, Prospective, Multi Center, Clinical study to evaluate efficacy and safety of AYUARTIS Capsules in subjects suffering from Osteoarthritis of Knee(s) - NI
Welex Laboratories Pvt Ltd0 sites31 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Sponsor
- Welex Laboratories Pvt Ltd
- Enrollment
- 31
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Symptoms of osteoarthritis in one or both knee joints for a minimum of Six months and maximum for five years.
- •2\. History of knee pain due to osteoarthritis requiring the use of NSAIDs Acetaminophen or another analgesic agent on a regular basis (greater than or equal to three days per week) for at least six months before the screening visit.
- •3\. OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s)
- •4\. Subjects taking tab Paracetamol (less than or equal to 2g per day) or any NSAID for breakthrough pain
- •5\.Subjects not having knee joint deformity
- •6\.Subjects with pain VAS greater than 40 mm on weight bearing activities
Exclusion Criteria
- •1\. Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
- •2\. 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\. 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\. Use of any analgesics except the study medication or paracetamol
- •6\. Use of systemic corticosteroids within 2 months of screening, or intra\-articular viscosupplementation within the past 3 months
- •7\. Use of any other investigational drug within 1 month prior to randomization
- •8\. Subjects having diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
- •9\. Known other major medical or surgical disease;
- •10\. Pregnancy \& Lactation.
Outcomes
Primary Outcomes
Not specified
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