non alcoholic fatty liver disease
Conditions
Interventions
administration of vitamin B6
Sponsors
Yokohama City University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 to 85 years old at the time of acquisition. 2) Patients with NAFLD who have ineffective diet exercise therapy for 3 months. 3) Patients who can understand written consent about participation, observe compliance matters, undergo examination prescribed in this research plan, and can declare symptoms. 4) Patient diagnosed as fatty liver by abdominal ultrasound. 5) Patients who have fat liver greater than S1 stage by MRI. 6) Patients with fibrosis grade F3 or lower by MRI. 7) Patients with ALT of 40 IU / I or higher at screening . 8) Patients without drinking habits. (Alcohol consumption is equivalent to ethanol per day, in men less than 30 g / day, in women less than 20 g.) 9) Patients who are suspected of vitamin B6 deficiency by clinical symptoms (angularitis, cheilitis, glossitis, acute / chronic eczema, seborrheic eczema, contact dermatitis, peripheral neuritis, radiation disorder).
Exclusion criteria
Exclusion criteria: 1) Patient who has a change in internal medicine within 3 months before acquiring consent. 2) Patients whom the drug is contraindicated for and who have a history of hypersensitivity to the ingredients of the drug. 3) Patients with complications of other hepatic diseases such as hepatitis C, hepatitis B, autoimmune hepatitis. 4) Patients with current or past medical history of severe cardiovascular system, blood system, respiratory system, liver, kidney, digestive system, or neuropsychiatric disorder. 5) Patients with drug-induced or symptomatic NAFLD. 6) Patients who participated in other clinical trials and received administration of test drugs within one month prior to the start of the study (calculated from the day of study drug administration). 7) Patients with insulin injections for diabetic patients. 8) Patients with history of abdominal gastrointestinal surgery excluding appendicitis. 9) Patients with breastfeeding or who may be pregnant. 10) Patients who are judged inappropriate as subjects of this research by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ALT from baseline at 12 weeks | — |
Countries
Japan
Contacts
Public ContactTakaomi Takaomi
Yokohama City University Graduate School of Medicine Department of Gastroenterology and Hepatology
Outcome results
None listed