Clinical trial: Extract of Curcuma Longa Complexed With Phosphatidilcholine(Motore®)in the Treatment of Adults With Knee Osteoarthritis (NCT02409381)

Eligibility criteria:
Inclusion Criteria:

          -  Participants of both sexes;

          -  Age greater than or equal to 40 years and less than or equal to 75 years;

          -  Clinical diagnosis of osteoarthritis of the knee (tibiofemoral joint) based on
             clinical and radiological criteria (Grade 2 and 3 Kellgren and Lawrence) as specified
             below:

          -  Pain on movement in the affected knee on most days of the last month, with at least
             partial relief at rest;

          -  Presence of osteophytes of at least 1 mm in radiological imaging, a report issued by a
             qualified professional from the center;

          -  Symptoms of osteoarthritis in the last 06 months preceding the start of the study;

          -  Visual Analogue Scale with 40mm or greater value (considering the data obtained at the
             randomization visit);

          -  Ability to understand and consent to participate in this clinical study, manifested by
             signing the Informed Consent Form (ICF).

        Exclusion Criteria:

          -  Any finding of clinical observation (clinical and physical examination) or laboratory
             finding that is interpreted by the researcher as a medical risk to participation in
             the clinical trial;

          -  Any finding of ECG examination the investigator physician considers risk as to the
             research participant about their participation in the clinical trial;

          -  Known hypersensitivity to the components of the medications used during the study;

          -  Women in pregnancy or nursing period;

          -  in premenopausal women who do not agree to use acceptable contraceptive methods (oral
             contraceptives, injectable contraceptives, hormonal implants, barrier methods,
             abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral
             oophorectomy or hysterectomy);

          -  concomitant arthropathy that may confuse or interfere with pain assessment or
             efficacy, including: inflammatory arthropathy (rheumatoid arthritis, systemic lupus
             erythematosus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatic), gouty
             arthritis, acute episodes of monoarthritis compatible with pseudogout, Paget's disease
             with involvement of the joint study, history of septic arthritis, avascular necrosis
             or intra-articular joint studied, Wilson's disease, hemochromatosis, alkaptonuria,
             primary osteochondromatosis fracture;

          -  Infectious Arthritis as gonococcal and syphilitic;

          -  History of significant collateral ligament injury, or anterior cruciate, or the
             meniscus of the joint study, requiring surgery or immobilization for more than three
             weeks (minor ligament injuries, six months prior to the study, are not exclusion
             criteria );

          -  History of arthroscopy of the affected knee during the six months preceding the entry
             of the research participant in the study;

          -  History of any illness that, in the opinion of the investigator, might confound the
             results of the study or research participant put on additional risk;

          -  Treatment with corticosteroids as follows:

          -  Use of corticosteroids orally or intramuscularly for one month prior to the
             randomization visit (V0);

          -  Administration of intra-articular corticosteroid, the joint study in the previous
             three months at randomization visit (V0);

          -  Administration of intra-articular corticosteroids in any joint a visit prior to
             randomization (V0) month;

          -  intra-articular injection of hyaluronic acid in the joint or congeners studied in the
             last twelve months prior to randomization visit (V0);

          -  Implementation of any other medical treatment for osteoarthritis in the
             pre-randomization visit (V0) months;

          -  Body Mass Index (BMI) equal to or greater than 35;

          -  Participant that is in use Prohibited Drug;

          -  the presence of serious psychiatric illness of any kind that prevents the proper
             performance of study-related procedures and good adherence to treatment;

          -  Participant that has some relation to the second degree of kinship or relationship
             with employees or employees of Sponsor and Research Center.
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 75 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? 1