Health Condition 1: null- Osteoarthritis of Knee
Conditions
Interventions
Intervention1: Ostofix Tablet: Each Film Coated Tablet Contains Commiphora mukul extract Boswellia serrata extract Vitex egundo extract Smilax china extract Trigonella foenum graecum extract Allium sa
Sponsors
ARJUN HEALTHCARE
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 •Subjects may take tab paracetamol greater than or equal to 2g per day or any standard analgesic drug 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 greater 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 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 and Lactation. •Known hypersensitivity to ingredients used in study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess efficacy of Ostofix Tablet in subjects suffering from Osteoarthritis of Knee by assessing 1 Knee Joint Pain on VAS 2 WOMAC Index Timepoint: Day 0 day 15 day 30 day 45 day 60 day 75 day 90 1 Knee Joint Pain on VAS 2 WOMAC Index | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Quality of life on SF -36 questionnaire 2) Assessment of time to walk 50 feet and distance between feet while walking 50 feet on even surface 3) Global assessment for overall improvement by the subject and by patient 4) Assessment of use of Tab Paracetamol or any standard analgesic drug as rescue medicine. 5) Assessment of Tolerability of the study drug 6) Assessment of safety laboratory investigations Timepoint: Day 0 day 15 day 30 day 45 day 60 day 75 day 90 | — |
Countries
India
Contacts
Public ContactDr Vaishali Deshpande
Sumatibhai Shah Ayurved Mahavidyalaya and Saneguruji Aarogya Kendra
Outcome results
None listed