The comparison of effect between salsalate and placebo in osteoarthritis patients with nonalcoholic fatty liver disease: investigator initiated randomized placebo-controlled double-blind, pilot study.

Koera University Guro Hospital0 个研究点目标入组 34 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1. Over 19 years old
•2. Osteoarthritis patients with nonalcoholic fatty liver
•3. Diagnostic criteria for nonalcoholic fatty liver (all satisfied)
•- Abdominal ultrasound image Fatty liver
•- Patients without evidence of other chronic hepatitis such as hepatitis B, hepatitis C, immune hepatitis, metabolic hepatitis
•- Less than 210 g drinking per week in men, less than 140 g drinking per week in women
•4. Osteoarthritis not receiving treatment

•1. Persons who do not meet the Inclusion criteria
•2. Thiazolidinedione is administered for the treatment of diabetes, or drug has been changed within the past 6 months
•3. Patients undergoing treatment such as nonsteroidal anti-inflammation for osteoarthritis
•4. Patients with renal impairment
•Serum creatinine level 1.5 mg / dL or creatinine clearance <60 mL / min
•5. Patients with a history of gastrointestinal bleeding
•6. Patients whose AST and ALT exceed 5 times the normal upper limit (200 IU / L)
•8. Pregnant or lactating women
•9. Other untreated malignant tumors
•10. Patients who received liver transplant
•11. Liver function Child-Pugh B or more patients
•12. In case of serious diseases judged to be able to affect the study (eg, congestive heart failure, renal failure, chronic pancreatitis, malignant tumor etc.)
•13. Patients with a history of having been administered the current immunomodulatory agent / immunosuppressant (including systemic corticosteroids administration) within 6 months prior to study registration
•14. Subjects judged to be nonconformities by other researchers
•: It must not be under any of the above exclusion criteria.

发起方

Koera University Guro Hospital