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Clinical study of Jiangzhi Xiaopi Decoction in the treatment of metabolism-related fatty liver disease (liver-depression and spleen-deficiency phenotype)

Clinical study of Jiangzhi Xiaopi Decoction in the treatment of metabolism-related fatty liver disease (liver-depression and spleen-deficiency phenotype)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083810
Enrollment
Unknown
Registered
2024-05-05
Start date
2024-05-05
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Metabolism-related fatty liver disease

Interventions

Experimental group:Lifestyle intervention + oral dicycloxylic alcohol tablets + Jiangzhi Xiaopi Decoction add or subtract
Control group:Lifestyle intervention + oral dicycloxylic alcohol tablets

Sponsors

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of MASLD Western Medicine; (2) TCM syndrome type is consistent with liver-stagnation and spleen-deficiency syndrome; (3) Age = 18 years old and ?80 years old, gender is not limited; (4) Liver function ALT, AST or GGT can be mildly to moderately elevated (not more than 5 times the upper limit of normal); (5) Subjects must agree to participate in the study and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: (1) steatosis and inflammation related factors that may be caused by alcoholic liver disease, hepatolenticular degeneration, autoimmune liver disease, chronic viral hepatitis, inflammatory bowel disease, total parenteral nutrition, hypothyroidism, ß-lipoprotein deficiency, Cushing's syndrome, insulin resistance related syndrome, and drugs; (2) with serious underlying diseases, mental diseases (hematopoietic system and liver, kidney, cardiovascular and cerebrovascular and other serious primary diseases, malignant tumors, other serious comorbidities or mental disorders); (3) People who are allergic or known to be allergic to the components of this medicine; (4) Women during pregnancy or preparing for pregnancy or breastfeeding; (5) Those who have taken liver protection drugs and antioxidants for a long time; (6) People who have recently taken or are taking drugs that cause elevated aminotransferase; (7) Severe liver function impairment, total bilirubin > 51umol/L, ALT>400U/L, AST>400U/L; Patients with cirrhosis or hepatocellular carcinoma; (8) Those who are participating in other clinical trials or have participated in other clinical trials in the last 3 months; (9) Suspected substance abuse history or other ineligible subjects.

Design outcomes

Primary

MeasureTime frame
TCM syndrome score;

Secondary

MeasureTime frame
Liver enzyme index;serum lipids;fasting blood sugar;glycosylated hemoglobin;Fasting insulin;BMI;Controlled attenuation parameters;visceral fat;Liver hardness number;body fat rate;Tumor necrosisfactor-a,TNF-a;Interleukin 6, IL-6;Pittsburgh Sleep Quality Index Scale;Nonalcoholic Fatty Liver Fibrosis Score (NFS Score);FIB-4 score;

Countries

China

Contacts

Public ContactJianyi Wang

Yueyang Hospital of Integrated Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

wjydyj@163.com+86 138 1632 4870

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026