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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046132
Enrollment
Unknown
Registered
2021-05-04
Start date
2021-05-06
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic fatty liver disease

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
MRI-pdff;

Secondary

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

Countries

China

Contacts

Public ContactZhao Yu

Shuguang Hospital Affiliated to Shanghai University of Chinese Medicine

cathy150@139.com+86 21 2056526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026