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Clinical Efficacy and Mechanism of Yinchen Linggui Zhugan Decoction in Non-Alcoholic Steatohepatitis Patients (with Phlegm-Turbidity Internal Obstruction and Damp-Heat Stasis Syndrome)

Study on the Clinical Efficacy and Mechanism of Yinchenlingui-Zhugan Decoction in Patients with NASH (Phlegm-Dampness Obstruction and Damp-Heat and Stasis Syndrome)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000770
Enrollment
Unknown
Registered
2026-03-27
Start date
2026-01-16
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Non-Alcoholic Steatohepatitis (NASH)

Interventions

Treatment Group:Yinchen Linggui Zhugan Decoction plus Essentiale Placebo
Control Group:Yinchen Linggui Zhugan Decoction Placebo plus Essentiale

Sponsors

Dongfang Hospital, Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Those who meet the Western medicine diagnostic criteria for Non-Alcoholic Steatohepatitis (NASH); 2.Those who meet the Traditional Chinese Medicine (TCM) diagnostic criteria for Phlegm-Turbidity Internal Obstruction and Damp-Heat Stasis Syndrome; 3.Those aged between 18 and 65 years of age; 4.Those who have not received treatment with drugs of the same category within 2 weeks before the trial (excluding Non-Alcoholic Steatohepatitis patients who are already taking antihypertensive or lipid-lowering drugs); 5.Those who voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with weekly alcohol consumption between light and heavy, and with unclear etiology of abnormal liver enzymes and fatty liver; 2.Patients with fatty liver disease not classified as Non-Alcoholic Steatohepatitis (e.g., acute fatty liver of pregnancy, fatty liver encephalopathy syndrome, lipid storage disease, fatty liver tumors, fatty liver caused by alcoholic liver disease or viral liver disease, etc.); 3.Patients with severe lesions of major organs such as the brain and kidneys, and those with mental illnesses; 4.Patients with hypertension or hyperlipidemia who are already receiving treatment; 5.Pregnant women and lactating women; 6.Patients who have used other drugs for Non-Alcoholic Steatohepatitis (NASH) treatment within 2 weeks before screening; 7.Patients with allergic diathesis, and those who are allergic to the known ingredients or any excipients of the study drug; 8.Patients with a history of drug abuse; 9.Patients who have participated in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Liver Enzymology;Blood Lipids;Controlled Attenuation Parameter(CAP);—

Secondary

MeasureTime frame
Abdominal B-ultrasound;Evaluation of Traditional Chinese Medicine Syndromes;—

Countries

China

Contacts

Public ContactZhibin Wang

Dongfang Hospital, Beijing University of Chinese Medicine

wangsanger@126.com18901347440

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026