Clinical trial: To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis (NCT01604239)

Eligibility criteria:
Inclusion Criteria:

          -  Minimum 19 years old

          -  Kellgren stage I ~ III by ACR criteria

          -  Stable osteoarthritis during 3 months

          -  Be able to perform WOMAC and KKS

          -  Written consent form voluntarily

        Exclusion Criteria:

          -  Disease of orthopaedic surgical that could affect to evaluate the efficacy

          -  Medication of continuous corticosteroid by oral or articular cavity within 12 weeks

          -  Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics
             within four weeks

          -  Medical history of hypersensitivity reaction against Herbal drug

          -  Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose
             malabsorption, etc.

          -  Occurrence of OA caused by the injury

          -  Diagnosed with psychical disorder, and taking medication

          -  Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel
             disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure,
             clinically significant ischemic heart disease, peripheral arterial disease, or
             cerebrovascular diseases

          -  Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it

          -  Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)

          -  Positive in fecal occult blood test

          -  Gastrointestinal tract surgery except appendectomy

          -  Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test

          -  Participation in another clinical trials within 4 weeks

          -  Not consent about using effectual contraception method during trial

          -  Pregnant or lactating woman

          -  Medical history of malignant tumor within 5 years

          -  Investigator's judgment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.


Patient description (medical language): A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Entailment