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Yunpi Lishi Formula in the treatment of non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Yunpi Lishi Formula in the treatment of non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084995
Enrollment
Unknown
Registered
2024-05-29
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

Non-alcoholic fatty liver disease

Interventions

Treatment group:Basic treatment (life, diet, exercise)+Yunpi Lishi Formula

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The Western Medical diagnostic criteria of NAFLD were met; 2. Meets the Traditional Chinese medicine syndrome differentiation for NAFLD; 3. The age ranged from 18 to 70 years old, regardless of gender; 4. They voluntarily accepted the treatment of Yunpi Lishi and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute fatty liver of pregnancy, Reye syndrome (acute encephalopathy complicated with visceral steatosis syndrome), lipoid deposition disease, focal fatty liver, hepatic fatty tumor, etc. 2. Viral hepatitis, drug-induced liver disease, total parenteral nutrition, hepatolenticular degeneration, autoimmune liver disease and other specific diseases can lead to fatty liver. 3. Alt, AST >= 5 x ULN, or TBIL >= 5 x ULN. 4. Patients took liver protecting drugs, lipid-lowering and weight-loss drugs within 2 weeks before entering the group. 5. Patients with heart, brain, kidney (BUN > 1.5 times of the upper limit of normal value, SCR > upper limit of normal value), hematopoietic system and other serious primary diseases, psychosis and clinically significant abnormal ECG. 6. A woman who is pregnant or ready to conceive, a lactating woman. 7. Those who are known to be allergic to ingredients of Yunpi Lishi Formula or allergic constitution. 8. Patients suspected of having a history of drug abuse or indeed reducing the possibility of enrollment. 9. Cognitive dysfunction can not give full informed consent. 10. Patients who participated in other clinical trials in the past month.

Design outcomes

Primary

MeasureTime frame
Measurement of proton density and fat content in magnetic resonance imaging;

Secondary

MeasureTime frame
liver function;blood fat;FibroScan;BMI;TCM clinical symptom score;

Countries

China

Contacts

Public ContactYueqiu Gao

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

gaoyueqiu@hotmail.com+86 137 9538 8789

Outcome results

None listed

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