Clinical trial: NGA-01 Gel for the Treatment of Osteoarthritis With Joint Pain (NCT04612283)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects having at least one or more sign and symptoms of Osteoarthritis like Pain in
             joints (at Knee, Hip, Ankle, Elbow and Shoulder), stiffness, difficulty in flexion and
             extension, crepitus, swelling etc for more than 3 months prior to the study.

          -  Pain score of at least 4 cm on a 10-cm linear visual analogue scale.

          -  Are free of any systemic or dermatologic disorder, which, in the opinion of the
             investigator, will interfere with the study results or increase the risk of adverse
             events.

          -  Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation
             (natural or artificial) for the duration of the study.

          -  Are willing to refrain from using any lotions, gel, balm, moisturizer, cleansers,
             cosmetics or creams, other than those issued as part of the study, on the treatment
             areas during the treatment period.

          -  If female of childbearing potential, must be willing to practice an acceptable form of
             birth control for the duration of the study.

          -  Are able to give written informed consent in a manner approved by the Institutional
             Ethics Committee and comply with the requirements of the study.

          -  Are willing to avoid participation in any other interventional clinical trial for the
             duration of this study.

        Exclusion Criteria:

          -  Are pregnant, breast-feeding, or planning to become pregnant during the study.

          -  Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis,
             Gouty Arthritis.

          -  Complications of OA, like Pseudogout, Spontaneous osteonecrosis of the knee, Ruptured
             Baker cyst, Bursitis, Anserine bursitis (knee)interfere with the disease and
             treatment.

          -  Severe Stomach infection.

          -  Severely traumatised and/or very severe or mucosal inflammation

          -  Peritonsillar abscess

          -  Long term use (≥ 3 times per week within the last month or regular intake within the
             last 3 months before randomisation) of antiinflammatory drugs- Any long-acting or slow
             release analgesic intake including Non Steroidal Anti-Inflammatory Drugs
             (NSAIDs)within 24 hours before randomisation (e.g. piroxicam or naproxen)

          -  Any anti-inflammatory drugs intake by systemic route within 12 hours before
             randomization

          -  Any paracetamol intake within 6 hours before randomisation

          -  Any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6
             hours before randomisation

          -  Heavy smokers (>10 cigarettes/day)

          -  Have open sores or open lesions in the treatment area(s).

          -  Have any condition that, in the opinion of the investigator, would confound the safety
             and/or efficacy assessments of plaque Arthritis.

          -  Have participated in any interventional clinical trial in the previous 30 days.

          -  Have a known sensitivity to any of the constituents of the test product

          -  Have used, are using, or are planning to use immunosuppressive or immunomodulatory
             medication (i.e., biologics), including oral or parenteral corticosteroids.

          -  Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or
             illegal drug/substance abuse in the past 2 years.

          -  Plan to seek alternative treatment of any kind for their Arthritis, in the eligible
             treatment areas or otherwise, during the trial period.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment