Clinical trial: Clinical Trial to Evaluate the Effects of a Nutraceutical in Patients Affected by Knee Osteoarthritis (NCT03612986)

Eligibility criteria:
Inclusion Criteria:

          -  Any gender and age from 45 to 70 years

          -  Symptomatic osteoarthritis (OA) of the knee with mild joint discomfort for at least 6
             months prior to enrollment, following ACR criteria with history and physical
             examination(44). Subjects diagnosed with bilateral knee OA will be asked to specify
             the most affected knee at baseline, and this knee will be evaluated throughout the
             study period.

          -  Available confirmatory X-ray (performed within the previous 6 months) diagnosis
             (Kellgren/Lawrence score 2) at the evaluated knee joint(45).

          -  Subjects experienced pain for at least 15 of the 30 days prior to the start of the
             study.

        Exclusion Criteria:

          -  Subjects who have any inflammatory arthritic condition (different from the OA of the
             knee), fibromyalgia, multiple sclerosis or autoimmune disorder.

          -  Treatment with oral corticosteroids within 4 weeks before screening.

          -  Intra-articular injections of HA or corticosteroids in the target joint within 3
             months before screening.

          -  Treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate,
             glucosamine, methylsulfonylmethane, HA, diacerein) 2 weeks before the selection.

          -  HA-containing nutritional supplements or cosmetics during the month before the study.

          -  Previous surgical treatment of knee joint(s) or its necessity necessity for
             osteoarthritis (high tibial osteotomy, arthroplasty); complication(s) necessary for
             hospitalization and surgical treatment.

          -  Significant injury to the target joint within the past 6 months prior to screening
             (identified from medical history).

          -  Subjects following an energy-restricted diet for weight loss.

          -  Pregnant women, nursing mothers, or women (only if childbearing potential) not using
             adequate methods of contraception.

          -  Subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or
             other medical or psychiatric condition that, in the opinion of the investigator, would
             compromise participation or be likely to lead to hospitalization during the course of
             the study.

          -  Participation in an interventional clinical study in the previous 30 days.

          -  Presence of any clinically significant medical condition judged by the investigator to
             preclude the patient's 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 45 Years old.
Subject must be at most 70 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