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Clinical and Mechanistic Study on Lianshi Jianpi Formula Regulating 'Gut Microbiota-Macrophage Polarization Axis' to Improve Phlegm-Dampness Constitution Metabolic Dysfunction-Associated Fatty Liver Disease

Clinical and Mechanistic Study on Lianshi Jianpi Formula Regulating 'Gut Microbiota-Macrophage Polarization Axis' to Improve Phlegm-Dampness Constitution Metabolic Dysfunction-Associated Fatty Liver Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001024
Enrollment
Unknown
Registered
2025-05-24
Start date
2025-05-26
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Metabolic Dysfunction-Associated Fatty Liver Disease

Interventions

Control group:lifestyle intervention
Healthy control group:No
Treatment group:Lifestyle intervention combined with Lianshi Jianpi Formula

Sponsors

People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Patients meeting the diagnostic criteria for Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD) with a predominant Phlegm-Dampness Constitution (as defined by TCM body constitution assessment); (2)Aged 18–65 years; (3)No participation in any drug clinical trials within the 3 months prior to enrollment; (4)Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients with a history of diabetes mellitus >5 years and/or current use of glucose-lowering medications; (2) Use of antibiotics probiotics antitumor agents or immunosuppressive drugs within the preceding 1 month; (3) Active oral pathologies including but not limited to acute/chronic periodontitis pulpitis oral neoplasms or cysts; (4)Diagnosis of gout or hyperuricemia (serum uric acid [UA] =540 µmol/L); (5)Special populations: Pregnant or lactating women or individuals with psychiatric disorders; (6)Patients with significant gastrointestinal disorders; (7)Concurrent severe systemic diseases including malignancies active infections immune disorders hematopoietic diseases or other major comorbidities.

Design outcomes

Primary

MeasureTime frame
Body Mass Index;Fasting insulin;Serum Lipids(TC\TG\LDL-C\HDLC);waist circumference;Traditional Chinese Medicine Syndrome Pattern Score;Liver Ultrasound;glycosylated hemoglobin;Traditional Chinese Medicine Constitution Scoring System;liver function(ALT\AST);Fasting blood glucose;Homeostasis Model Assessment of Insulin Resistance;

Secondary

MeasureTime frame
Renal function(Creatinine\Blood Urea Nitrogen\Glomerular filtration rate);transforming growth factor-ß;Tumor Necrosis Factor-alpha;short-chain fatty acid;Stool gut microbiota detection;Interleukin 10;interleukin-6;Human IL-1 beta protein;

Countries

China

Contacts

Public ContactMingqian Jiang

People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine

JMQian1130@hotmail.com18850351500

Outcome results

None listed

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