Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: AYUARTIS Capsules: AYUARTIS Capsules contains Withania somnifera, Boswellia serrata extract, Cyperus rotundus, Paederia foetida extract, Vitex negundo extract, Holarrhena antidysenteric
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion 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
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. 11. Known hypersensitivity to ingredients used in study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1). Knee Joint Pain on VAS 2). WOMAC Index Timepoint: Day -7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Quality of life on Karnofsky and Lansky Performance Score 2) Time to walk 50 feet on even surface. 3) Global assessment for overall improvement by the subject 4) Global assessment for overall improvement by the investigator 5) Assessment of use of Tab Paracetamol or any NSAIDs as rescue medicine 6) Tolerability of the study drugs evaluated by number of Adverse Drug Reactions. 7) Safety laboratory parametersTimepoint: Day -7, Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed