Clinical trial: To Assess the Lanconone® (E-OA-07) Efficacy in Physical Activity-related Pain- LEAP Study (NCT03262805)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Contradiction