Health Condition 1: null- Osteoarthritis of Knee
Conditions
Interventions
Intervention1: FR 54: Composition:
Pudina ka phool (Menthol) (Mentha arvensis), Karpoor (Cinnamomum comphora), Gaultheria ka Tel (Wintergreen Oil) (Gaultheria procumbens), Ajwain ka Phool (Carum
Sponsors
Emami Limited
Eligibility
Inclusion criteria
Inclusion criteria: •Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years • 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 •OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s) •Subjects may take tab paracetamol (Less than of equal to 2g per day) for breakthrough pain •Subjects not having knee joint deformity •Subjects signing written informed consent and ready to comply with the protocol requirements •Subjects with pain VAS reater than 40 mm on weight bearing activities
Exclusion criteria
Exclusion criteria: • Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease • History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit • Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study • 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 • Use of any analgesics except the study medication or paracetamol; • Use of systemic corticosteroids within 2 months of screening, or intra-articular viscosupplementation within the past 3 months • Use of any other investigational drug within 1 month prior to randomization; • Subjects having diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease • Known other major medical or surgical disease; • Pregnancy & Lactation. • Known hypersensitivity to ingredients used in study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1). Knee Joint Pain on VAS 2). WOMAC Index Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1). Quality of life on SF -36 questionnaire 2). Global assessment for overall improvement by the subject himself/herself at the end of 28 days of study treatment. 3). Global assessment for overall improvement by the investigator at the end of 28 days of study treatment 4). Onset and Duration of action of drugs 5). Cooling, counter irritation and warmness effects 6). tolerability of the study drugs evaluated by number of Adverse Drug ReactionsTimepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
TARGET INSTITUTE OF MEDICAL EDUCATION & RESEARCH, Mumbai
Outcome results
None listed