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A multicenter randomized controlled clinical study on the treatment of MAFLD patients with dampness and turbidity internal obstruction syndrome by Qinghua Formula

A multicenter randomized controlled clinical study on the treatment of MAFLD patients with dampness and turbidity internal obstruction syndrome by Qinghua Formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002364
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

MAFLD

Interventions

The experimental group:received lifestyle intervention assisted by the Xiaoxinhgan app combined with Qinghua Formula
the control group :received lifestyle intervention assisted by the Xiaoxinhgan app

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients meeting the diagnostic criteria for MAFLD in Western medicine; 2. Patients meeting the diagnostic criteria for dampness and turbidity obstruction syndrome in Traditional Chinese Medicine; 3. Patients aged =18 years and =75 years; 4. Overweight/obese: BMI = 24 kg/m², or waist circumference: = 90 cm for men and = 85 cm for women; 5. If there is abnormal glucose metabolism or type 2 diabetes: fasting blood glucose = 6.1 mmol/L, or 2-hour postprandial blood glucose = 7.8 mmol/L, or HbA1c = 5.7%, or a history of type 2 diabetes, or HOMA-IR = 2.5; 6. If there is abnormal lipid metabolism: fasting serum triglycerides = 1.7 mmol/L, or on lipid-lowering drug treatment; or serum high-density lipoprotein cholesterol - = 1.0 mmol/L for men and = 1.3 mmol/L for women, or on lipid-lowering drug treatment; 7. If there is abnormal liver function: ALT or AST or ?GT = 1 ULN, or on liver enzyme-lowering drug treatment; 8. Patients who have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with other chronic liver diseases such as other viral liver diseases autoimmune liver diseases alcoholic liver diseases drug-induced liver diseases or liver malignancies; 2. Patients with Child-Pugh grade > A; 3.Pregnant or lactating women women of childbearing age who have not taken effective contraceptive measures or male subjects who are unwilling to use contraceptive measures; 4.Patients with severe primary cardiovascular diseases kidney diseases hematological diseases lung diseases tumors AIDS or other serious diseases that affect survival; such as abnormal renal function creatinine higher than the upper limit of normal. Clinically significant arrhythmias. 5.Patients without or with limited capacity for civil conduct; 6.Patients suspected or confirmed to have a history of alcohol or drug abuse; 7.Patients known to be allergic to the components of this medicine; 8.Patients who have participated in other clinical trials within the past 3 months; 9. Patients who have used traditional Chinese medicines or Chinese patent medicines with the same or similar efficacy as Qinghua Formula within the past month; 10. Patients deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Liver CAP;

Secondary

MeasureTime frame
liver B-ultrasound;TCM syndrome score;

Countries

China

Contacts

Public ContactYing Li

Longhua Hospital Shanghai University of Traditional Chinese Medicine

13817270542@163.com13817270542

Outcome results

None listed

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