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Yuanqing Clinical study on the effects of hepatic steatosis in patients with nonalcoholic fatty liver disease: a single-center randomized controlled trial protocol

Yuanqing Clinical study on the effects of hepatic steatosis in patients with nonalcoholic fatty liver disease: a single-center randomized controlled trial protocol

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078840
Enrollment
Unknown
Registered
2023-12-19
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Control group:Yuan Qing placebo specific dosage refer to the instructions. Every 30 days for a course of treatment, a total of 3 courses.
Case group:Yuan Qing specific dosage refer to the instructions. Every 30 days for a course of treatment, a total of 3 courses.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria for nonalcoholic fatty liver disease (see Guidelines for Prevention and Treatment of nonalcoholic Fatty Liver Disease); ? Not less than 18 years old and not more than 60 years old; ? Agree and sign informed consent.

Exclusion criteria

Exclusion criteria: ? Patients with serious diseases of the heart, kidney, brain, lung, blood, digestive system or mental illness; ? Pregnant or lactating women; ? Situations where other clinicians consider it inappropriate to participate in clinical research; ?Patients with a significant history of alcohol consumption (AUDIT questionnaire) or whose alcohol consumption cannot be quantified; ?Long-term use (more than 2 weeks) in the past year of drugs that can cause liver steatosis or steatohepatitis (glucocorticoids, tetracycline, anabolic steroids, valproic acid, salicylate, tamoxifen), or use of drugs with significant liver toxicity; ?Suffering from other liver diseases (such as viral hepatitis, immune hepatitis, drug-induced hepatitis, etc.) or have received a liver transplant; ?Suffering from immune system disease, cancer or kidney disease; ?Suffers from diabetes; ?Patients who are currently enrolled in another clinical trial or have received an investigational drug within the past 60 days; ?MRI is not possible due to metal equipment, claustrophobia or other reasons; ?Changes in diet, exercise habits, or body weight in the last three months (5% or more).

Design outcomes

Primary

MeasureTime frame
liver lipid contents;

Secondary

MeasureTime frame
serum lipid parameter;visceral fat area;fatty liver (FL) index;HOMA-IR;

Countries

China

Contacts

Public ContactQinghua Yin

West China Hospital, Sichuan University

80441279@qq.com+86 135 4068 4600

Outcome results

None listed

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