Clinical trial: Efficacy and Safety of Tabetri on Osteoarthritis (NCT03757611)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female 40 ~ 75 years of age

          -  VAS (Visual Analogue Scale) over 30mm

          -  Kellgren & Lawrence Grade I~II by X-ray

          -  Subject who agrees to participate in this clinical trial by themselves and signs the
             Informed Consent Form (ICF)

        Exclusion Criteria:

          -  Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia,
             systemic lupus erythematosus, septic arthritis, gout)

          -  Joint space under 2 mm by X-ray

          -  Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular
             surfaces, or subchondral bone cyst by X-ray

          -  Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases,
             tumor diseases

          -  Subjects having gastrointestinal diseases

          -  Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)

          -  Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)

          -  Patients with TSH <= 0.1 uIU/mL or >= 10 uIU/mL

          -  Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of
             the normal values)

          -  Subjects have attended abnormal values at creatinine (2 times excess at upper limit of
             the normal values)

          -  Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months

          -  Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to
             screening

          -  Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)

          -  History of osteoarthritis treatment therapy within 2 weeks prior to screening

          -  Have participated in another clinical trial within the 3 months prior to screening

          -  Subjects who have hypersensitivity history about investigational product

          -  Have difficulty to be participated in this clinical trial by investigator's decision
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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? Entailment