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Re evaluation of the clinical efficacy of Ganzhixiao capsules based on MRI-PDFF in the treatment of metabolic related fatty liver disease

Re evaluation of the clinical efficacy of Ganzhixiao capsules based on MRI-PDFF in the treatment of metabolic related fatty liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000097
Enrollment
Unknown
Registered
2025-01-14
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

MAFLD

Interventions

ganzhixiao group:ganzhixiao capsule

Sponsors

Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age between 18 and 70 years old with a body mass index (BMI) of at least 24kg/m2; 2) Diagnosis of NAFLD determined by imaging [ultrasound computed tomography or magnetic resonance imaging (MRI-PDFF)] or liver biopsy showing MAFLD or simple steatosis within the last 24 months prior to screening; 3) MAFLD patients conform to the damp heat syndrome type; 4) Voluntary signing of informed consent form

Exclusion criteria

Exclusion criteria: 1) Blood biochemical indicators ALT AST BUN are greater than 1.5 times the upper limit of normal values Cr is greater than the upper limit of normal values eGFR<60ml/min/1.73m2; 2) Alcoholic fatty liver other chronic liver diseases cirrhosis liver malignant tumors etc.; 3) Type 2 diabetes and pancreatic diseases; 4)Taking some hypoglycemic lipid-lowering liver protective drugs or high-dose vitamin E that may affect the efficacy judgment in the past three months ; 5) Patients with severe infections cardiovascular respiratory renal hematological rheumatic connective tissue disease neuropsychiatric and non liver malignant tumors; 6) Pregnant or lactating women; 7) Those who require long-term hormone therapy; 8) Researchers anticipate poor compliance or inability to cooperate; 9) There are contraindications for MRI examination including pacemakers or cochlear implants postoperative artificia

Design outcomes

Primary

MeasureTime frame
Liver fat content;

Secondary

MeasureTime frame
ALT;body weight;CK18;PSQI;Waist hip height ratio;BMI;FIB-4;waist to hip ratio;hip circumference;LSM;Damp Heat Traditional Chinese Medicine Syndrome Scale;waist circumference;Zung Depression Self Rating Scale;Zung Self Rating Anxiety Scale;

Countries

China

Contacts

Public ContactHui Dong

Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology

tjhdonghui@163.com15337102249

Outcome results

None listed

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