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Clinical Assessment and Mechanism Research of Jianpi Huashi Method () via Gut Flora-Glycolipid Metabolism Modulation in MAFLD Patients with Pi-Xu Shi-Kun Zheng ()

Clinical Assessment and Mechanism Research of Jianpi Huashi Method () via Gut Flora-Glycolipid Metabolism Modulation in MAFLD Patients with Pi-Xu Shi-Kun Zheng ()

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000865
Enrollment
Unknown
Registered
2025-04-27
Start date
2025-06-01
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

metabolic associated fatty liver disease

Interventions

Qi-Zhu:Qi-Zhu Formula
control group:Metformin

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Meets the diagnostic criteria for MAFLD (Metabolic Associated Fatty Liver Disease) according to Western medicine. 2.Meets the syndrome differentiation criteria for spleen deficiency with dampness obstruction in Traditional Chinese Medicine. 3.Aged 18-70 years with no restriction on gender. 4.Informed consent has been obtained for participation in this study.

Exclusion criteria

Exclusion criteria: 1.Individuals with comorbid autoimmune diseases medication use pregnancy or other conditions that may lead to hepatic steatosis. 2.ALT levels exceeding three times the upper limit of normal. 3.Individuals with MAFLD that has progressed to cirrhosis or hepatocellular carcinoma. 4.Pregnant women women planning pregnancy or breastfeeding women. 5.Individuals with severe allergic constitutions or those who have a known allergy to the medications used in this study.

Design outcomes

Primary

MeasureTime frame
Diagnostic indicators;

Secondary

MeasureTime frame
Efficacy indicators of TCM syndrome;Biological indicators;Disease efficacy indicators;Safety metrics;

Countries

China

Contacts

Public ContactDongcan

Nanjing Hospital of Traditional Chinese Medicine

490678345@qq.com13770320432

Outcome results

None listed

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