Clinical Efficacy Evaluation of Jianpi Huoxue Decoction in the Treatment of Non-alcoholic Fatty Liver Disease

Phase 1

Recruiting

• Conditions: onalcoholic fatty liver disease

• Registration Number: ITMCTR2100004809
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patient who meet the diagnostic spleen deficiency and blood stasis syndrome of non-alcoholic fatty liver;
2.Aged 18 to 65 years;
3.MRI-pdff liver fat content > 5%, BMI < 35 kg/m2;
4.Voluntarily follow scheduled medical visits, dietary and exercise instructions, laboratory tests, and other study procedures;
5.ALT less than or equal to 5 times upper than normal limit;
6.Sign patient informed consent.

Exclusion Criteria

1.Someone who have used liver protection drugs and enzyme lowering drugs which can impact on efficacy evaluation in the past 1 month;
2.Someone who have used Tamoxifen, Amiodarone, sodium valproate, methotrexate, glucocorticoids or other drugs which can affects lipid metabolism in the past 3 month;
3.Someone who has comorbidity just like total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing's syndrome, ß-lipoprotein deficiency, lipid atrophic diabetes, Mauriac syndrome and other disease can lead to fatty liver disease;
4.Someone who has alcoholic fatty liver disease (male alcohol intake>30g/d, female alcohol intake>20g/d), cirrhosis, Hepatitis B, Hepatitis C and other liver diseases, autoimmune liver disease or liver decompensating;
5.T2DM patients whose disease without well control (HbA1c >= 9.5% in the past month);
6.ASCVD in high and very high-risk patients;
7.Someone whose weight lose 10% in the past 3 months because of bariatric surgery or diet pills;
8.Someone who with history of substance abuse or drug addiction;
9.Pregnant and lactating women, patients with cardiovascular, lung, kidney, hematopoietic system and other major primary diseases as well as malignant tumor.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI-pdff;

Secondary Outcome Measures

Name	Time	Method
Serum liver function;Blood fat;TCM syndrome scale integral;Weight, body mass index, waist circumference;Sf-36 Health Survey Scale score, non-alcoholic fatty liver disease questionnaire;Fasting blood glucose, fasting insulin, insulin resistance index;