To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study (LEAP)

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee OA, Joint Pain, Dietary supplement, WOMAC, Lequesne index, hs-CRP Read More

Inclusion Criteria:

• M/F subject aged ≥ 40 to ≤ 65 with unilateral or bilateral OA of the knee for greater than 3 months as presented by pain in knee.
• Body mass index (BMI) must be 25 to 29.9 kg/m2.
• WOMAC pain score for index joint: 10 to 16.
• Physically active subjects as indicated by day to day involvement in the mentioned physical activity namely:
• Daily walk of 500 to 1000 meters.
• Routine activities such as descending/ ascending stairs, standing up from a chair; bending to floor; travelling by public transport, domestic cleaning etc.
• Climbing 1 or more fleets of stairs.
• Osteoarthritis grade I/ II (Kellgren-Lawrence classification) as confirmed by radiographic evidence.

Exclusion Criteria:

• Subjects with a history of any joint replacement surgery.
• Subjects not willing to abstain from use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health/ local analgesics or other traditional pain relieving therapies such as message or acupuncture etc. during the study duration will be excluded.
• Subject with uncontrolled hypertension (blood pressure: systolic ≥140 mm Hg or diastolic ≥ 100 mm Hg) at screening.
• Subjects with history of thyroid hormone derangement will have to provide a recent (within 3 months) thyroid profile report indicative of euthyroid status.
• Use of any immunosuppressive drugs in the last 12 months.
• Use of any corticosteroids drugs in the last 3 months.
• Subject unwilling to refrain from analgesic measures at least 48 hours before each site visit.
• FBS >140 mg/dl.
• History of restless leg syndrome.
• Glucocorticoid injection or hyaluronic acid injection in affected joint within 3 months prior to enrolment.
• Subjects with a chronic pain syndrome and in the judgment of the Investigator is unlikely to respond to any therapy.
• Smokers and tobacco users.
• Alcohol consumption of more than 200 ml/ week
• History of surgery in lower limb.
• Subjects suffering from diabetic neuropathy.
• Subjects suffering from deep vein thrombosis.
• Pregnant / lactating women and women who are planning to get pregnant.
• Recent (< 3 months) participation in a clinical study.
• History of major chronic hepatic, cardiovascular, neurological or immunosuppressive conditions or the presence of any infections.
• Subjects with localized trauma to the lower limb.
• A psychiatric condition, chronic alcohol or drug abuse problem as evidenced by withdrawal symptoms.
• Subjects planning to travel in the next 35 days or engage in any non-routine activity that is likely to strain the knees.
• Subject a history of malignancy, active gastrointestinal disease, chronic or acute renal/hepatic disorders, or significant coagulation disorders.
• Subjects on vitamins, nutritional supplement or herbal product since last 2 weeks.
• Subjects otherwise judged by the investigator to be inappropriate for inclusion in the study.