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The therapeutic effect and immune regulatory mechanism of Yinchen Linggui Zhugan Decoction in the treatment of non-alcoholic steatohepatitis

The therapeutic effect and immune regulatory mechanism of Yinchen Linggui Zhugan Decoction in the treatment of non-alcoholic steatohepatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001606
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Non-alcoholic steatohepatitis

Interventions

Treatment group:Yinchen Linggui Zhugan Decoction Granules: Take twice a day one bag in the morning and one in the evening dissolved in water. Polyene phosphatidylcholine Capsule Simulator: Take 2 cap
Control group:Yinchen Linggui Zhugan Decoction Granules Simulation Agent: Take twice a day one bag in the morning and one in the evening dissolved in water. Polyene phosphatidylcholine Capsules: Take

Sponsors

Shenzhen Bao 'an District Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Meet the Western medicine diagnostic criteria for NASH; 2) Meet the traditional Chinese medicine diagnostic criteria for phlegm-turbidity internal obstruction and dampness-heat stasis binding syndrome; 3) Age between 18 and 65 years; 4) No treatment with the same category of medication within two weeks prior to the trial (excluding NASH patients already taking antihypertensive or lipid-lowering drugs); 5) Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with weekly ethanol consumption between moderate and excessive levels, in whom the etiology of abnormal liver enzymes and fatty liver is difficult to determine; 2) Patients with non-NASH fatty liver disease (e.g., acute fatty liver of pregnancy, fatty liver syndrome with encephalopathy, lipid storage diseases, hepatic fatty tumors, alcoholic liver disease, viral hepatitis-associated fatty liver, etc.); 3) Patients with severe pathologies of major organs such as the brain or kidneys, or with psychiatric disorders; 4) Patients with hypertension or hyperlipidemia who are already undergoing treatment; 5) Pregnant or lactating women; 6) Patients who have used other medications for NASH within two weeks prior to screening; 7) Individuals with allergic constitutions, or those allergic to any known component or excipient of the investigational drug; 8) Patients with a history of drug abuse; 9) Individuals who have participated in other clinical trials within the past three months.

Design outcomes

Primary

MeasureTime frame
Liver enzymology;Blood lipid;Liver fat attenuation parameters;

Secondary

MeasureTime frame
Abdominal B-ultrasound;Therapeutic effects of syndromes in traditional Chinese medicine;

Countries

China

Contacts

Public ContactXie Chune

Shenzhen Bao 'an District Hospital of Traditional Chinese Medicine

xiechune@sina.com13651014735

Outcome results

None listed

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