Non-alcoholic fatty liver disease
Conditions
Interventions
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years male and female; 2. Meet the diagnostic criteria of non-alcoholic fatty liver disease; 3. Meet the pattern differentiation criteria of yang deficiency of spleen; 4. Sign the inform content and agree to participate in every visit, examinations and treatment according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Combine with other specific liver diseases which would induce fatty liver, including but not limited to alcoholic liver disease, chronic hepatitis c, autoimmune liver disease,and hepatocellular degeneration; 2. Fatty liver induced by drugs (e.g. tamoxifen, ethylamine iodifurone, valproate, methotrexate, glucocorticoid), total parenteral nutrition, inflammatory bowel disease, hypothyroidism,Cushing syndrome, abetalipoproteinemia, and other syndromes related to insulin-resistance (e.g. lipid atrophic diabetes, Mauriac syndrome); 3. Combine with serious primary diseases, including cardiovascular and cerebrovascular diseases, liver diseases, kidney diseases and hematological diseases, cancer, and other severe complications and mental diseases; 4. Combine with diabetes and participants who are on anti-diabetic medicine treatment; 5. Currently receive treatments for non-alcoholic fatty liver disease (including Chinese herbal decoction, Chinese patent medicine, and chemical agents); 6. Received antibiotics in recent one month or currently receive antibiotics; 7. Participants who are known to be allergic to the composition of product or possess allergic constitution; 8. Pregnant and lactating women, and the women who are likely to be pregnant but refuse to keep predefined contraception measures during the study; 9. Participated in other clinical trials in recent three months or currently join another trial; 10. Mentally or legally disabled; 11. Cannot obey medical advice for therapeutic lifestyle modifications; 12. Suspicious of drug abuse or possess other forbidden criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients percentage who reaches one standard unit decrease of HOMA-IR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammation markers;Liver function;Blood lipid metabolism;Blood glucose metabolism;Inflammatory cytokines;Liver-kidney echo ratio by ultrasound;Body weight;Body mass index;Quantitative rating of clinical symptoms and signs;MOS item short from health survey, SF-36;Self-rating Depressive Scale;Self-rating Anxiety Scale; | — |
Countries
China
Contacts
Public ContactZheng Peiyong
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed