Clinical trial: Turmeric Efficacy for Mobility and Joint Function (NCT04506411)

Eligibility criteria:
Inclusion Criteria:

          -  Consent to the study and to comply with study product

          -  Who have a BMI between 18 and 32 kg/m²

          -  Who has mild to moderate knee pain for at least 3 months before enrollment (VAS
             between 40 to 70 on 100mm scale after respecting a washout period depending on the
             half-life of the excluded medications)

          -  Who has radiographic evidence of Kellgren-Lawrence score 0, 1, 2 and 3 in the
             tibio-femoral compartment of the target knee

          -  Who is able to perform the physical performance-based tests and understands all
             questions from the WOMAC questionnaire

          -  Who is willing to refrain from taking any pain reliever (OTC or prescription) and
             other pharmacological, nutritional agent (e.g. glucosamine), device or therapy (e.g.
             acupuncture) which may influence the study outcome during the entire trial (other than
             determined authorized rescue medication)

          -  Who is willing to not change dietary habits, level of physical activity (including any
             heavy physical work with high loading of the knee joints) and body weight

        Exclusion Criteria:

          -  Subjects with any clinically significant levels of the safety parameters at screening

          -  Pregnant or lactating females, or wishing to become pregnant during the study

          -  Subject with joint pain related to some predisposing conditions that have adversely
             altered the joint tissues often due to a specific cause

          -  Subject with Kellgren-Lawrence grade 4 in the tibio-femoral compartment of the target
             knee

          -  Who has clinically apparent tense effusion of the target knee or other joint

          -  Who has/had viscosupplementation in any joint including the target knee or other joint
             within 6 months prior to screening

          -  Who has concomitant inflammatory disease or other condition that affects the joints
             deemed exclusionary by the Principal Investigator (e.g. rheumatoid arthritis,
             metabolic bone disease, psoriasis, gout, symptomatic chondrocalcinosis and active
             infection, etc…)

          -  Who has symptomatic osteoarthritis of the contralateral knee that is not responsive to
             paracetamol and requires other therapy

          -  Who is taking any treatment/supplementation which may interfere with study conduct and
             interpretation of study results (4-weeks washout, e.g. glucosamine, chondroitin,
             corticosteroids) except calcium and vitamin D supplements

          -  Who is under any medical condition deemed exclusionary by the Principal Investigator

          -  Subject has a history of drug and / or alcohol abuse at the time of enrollment

          -  Change of dietary habit within the preceding month

          -  Subject with known organic disease, including an inflammatory bowel disease, a benign
             or malign tumor of intestine or colon and significant systemic disease

          -  Subject currently involved in any other clinical trial or having participated in a
             trial within the preceding 90 days

          -  Subject with known allergy to components of the test product

          -  Subject has any concurrent medical or psychiatric condition that, in the opinion of
             the Investigator, would compromise his/her ability to comply with the study
             requirements

          -  History of cancer within the last 5 years, except basal cell carcinoma, non-squamous
             skin carcinoma, prostate cancer or carcinoma in situ with no significant progression
             over the past 2 years

          -  Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune
             disorder, or metabolic/endocrine disorders or other disease that would preclude
             supplement ingestion and/or assessment of safety and the study objectives

          -  Current illnesses which could interfere with the study (e.g. prolonged severe
             diarrhea, regurgitation/severe, difficulty swallowing)

          -  Who is taking any anticoagulant or heparin treatment
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 80 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