Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention1: AQUA-TURM®: AQUA-TURM® contains water-soluble turmeric extract standardized to not less than 30% total Curcuminoids. â?? 250 mg
Dosage and Treatment Duration:
As per computer genera
Sponsors
Lodaat Pharma
Eligibility
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1). Comparative change in knee Joint Pain on VAS between two groups 2). Comparative change in WOMAC Index between two groups Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1). Comparative change in time to walk 50 feet while walking on even surface 2). Comparative change in use of Paracetamol or NSAID as rescue medicine 3). Comparative change in knee joint swelling 4). Comparative Change in CRP level between two groups 5). Comparative changes in the X Ray of Knee Joint 6). Comparative change in global assessment for overall change by investigator and subject 7). Comparative assessment of tolerability of study products by investigator and subject 8). Adverse events assessment 9). Comparative assessment of safety by assessing safety lab parameters Timepoint: Day -3, Day 0, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed