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Clinical evaluation of Kuhuang Granules in the treatment of nonalcoholic steatohepatitis

Clinical evaluation of Kuhuang Granules in the treatment of nonalcoholic steatohepatitis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003709
Enrollment
Unknown
Registered
2020-08-25
Start date
2020-10-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

nonalcoholic steatohepatitis

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Participate and sign the informed consent form voluntarily; 2. The age ranged from 18 to 60 years old; 3. According to the diagnosis of nonalcoholic steatohepatitis, the liver fat content was more than 5%, ALT 1 x ULN; 4. Those who have not used other drugs for the treatment of nonalcoholic steatohepatitis within 3 months.

Exclusion criteria

Exclusion criteria: 1. Nash related cirrhosis; 2. LDL > 4.14 mmol/L (indication for statins) or TG>5.6mmol/L (indication for fibrates); 3. Those who are using heparin, thyroxine and other drugs that affect fat metabolism; 4. Serious primary cardiovascular, liver, kidney, lung and hematological diseases, or serious diseases affecting survival, such as tumor or AIDS; 5. Pregnant and lactating women; 6. Those who have mental disorders can not give full informed consent; 7. People with allergic constitution or known to be allergic to the components of the drug; 8. Patients receiving other trial drugs within 3 months.

Design outcomes

Primary

MeasureTime frame
liver CAP value;Analysis of liver fat content by magnetic resonance imaging;liver function (ALT, AST, AKP, GGT);

Secondary

MeasureTime frame
waist-hip ratio;NAFLD liver fibrosis score;blood lipids;Body Mass Index;blood sugar;Insulin resistance index;CK18 level;weight;APRI;

Countries

China

Contacts

Public ContactLyu Jing

The Institute of Liver Disease, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

ljliver@163.com+86 13681663572

Outcome results

None listed

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