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Clinical evaluation of Yinchenhao decoction in the treatment of Nonalcoholic Fatty Liver Disease (hepatobiliary dampness-heat syndrome): a randomized controlled trial.

Clinical evaluation of Yinchenhao decoction in the treatment of Nonalcoholic Fatty Liver Disease (hepatobiliary dampness-heat syndrome)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034868
Enrollment
Unknown
Registered
2020-07-22
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-08-03

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

Conditions

Nonalcoholic Fatty Liver Disease

Interventions

Sponsors

Shuguang Hospital affiliated with Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Referring to the diagnostic criteria of NAFLD in the guidelines for the prevention and treatment of non-alcoholic fatty liver disease (2018 update), the diagnostic criteria of hepatobiliary dampness-heat syndrome established by the consensus opinion on the diagnosis and treatment of non-alcoholic fatty liver disease by integrated traditional Chinese and western medicine (2017) are as follows: 1. Between the ages of 18 years and 60 years (including), there is no limit on sex; 2. Patients who meet the diagnostic criteria of NAFLD,Liver imaging findings meet the diagnostic criteria of diffused fatty liver, and there is no other reason to explain and / or have metabolic syndrome related components in patients with unknown causes of serum ALT, / or AST, GGT continued to increase for more than half a year. 3. Meet the diagnostic criteria of liver and gallbladder dampness-heat syndrome of traditional Chinese medicine. 4. MRI PDFF mean >= 8%, Willing to accept regular physical and chemical examinations related to fatty liver; 5. I or my guardian agree to participate in the clinical trial control study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 5*ULN, total bilirubin (TBIL) > 2*ULN; 2. Alcoholic fatty liver (male alcohol intake > 210g/week, female alcohol intake > 140g/week); 3. Combined with viral, autoimmune and other liver diseases, or taking drugs that may cause fatty liver; 4. Combined with diabetes (glycated hemoglobin >= 6.5%, or fasting blood glucose >= 7.0mol/L, or 2 hours postprandial blood glucose >= 11.1mmol/L), malignant tumors, connective tissue diseases and severe heart, liver, hematopoietic, and nervous system complications , Or clearly have other important diseases; 5. Pregnant or breastfeeding women, allergic physique, allergic to drugs, and patients with mental illness; 6. Patients who have undergone gastrointestinal bariatric surgery within the past year or who have taken weight-loss drugs within the past three months have lost >10%.

Design outcomes

Primary

MeasureTime frame
MRI PDFF;

Secondary

MeasureTime frame
Fibro Touch (CAP);liver function;blood fat;Uric Acid;B-scan ultrasonography;scores of TCM syndrome;weight;waist;

Countries

China

Contacts

Public ContactZhang Hua

Institute of Liver Disease, Shuguang Hospital affiliated with Shanghai University of TCM

lnutcmzh@126.com+86 13524968650

Outcome results

None listed

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