Hao Qin Xiao Zhi Fang in the treatment of metabolic dysfunction-associated steatotic liver disease: A randomized controlled study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086661

Enrollment

Unknown

Registered

2024-07-08

Start date

2024-07-17

Completion date

Unknown

Last updated

2024-07-15

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

Conditions

metabolic dysfunction-associated steatotic liver disease

Interventions

HQXZF treatment group:Take Hao Qin Xiao Zhi Fang continuously for 12 weeks, take one dose daily, divide morning and evening twice, take half an hour after meal,and lifestyle guidance was given to the

Control Group:Lifestyle guidance

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ?according to the diagnostic criteria of metabolic fatty liver disease; ? according to the TCM diagnosis of damp-heat accumulation syndrome of metabolic fatty liver disease; ? BMI < 35kg/m2; ? age 18-65 years old, gender is not limited; ? voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: ?serum ALT, AST, ALP or GGT > 1.5 upper limit of normal value (ULN) , total bilirubin (Tbil) > 21 µmol/l; ?liver diseases complicated with alcoholic liver disease, viral liver disease, drug-induced liver disease, total parenteral nutrition, Wilson disease, autoimmune liver disease and so on, which need other therapeutic measures; ?imaging diagnosis of advanced liver fibrosis, cirrhosis, primary liver cancer, or liver cirrhosis (LSM)=12 kpa; ?patients with acute or chronic gastrointestinal diseases (including diarrhea, gastrointestinal infection, inflammatory bowel disease) , malignant tumor, severe renal insufficiency, cardiovascular disease, etc. ? those who are using drugs related to liver diseases, regulating blood glucose and lipid metabolism, or participating in other clinical trials; ?Use weight-loss drugs or join a weight-loss program in the past 4 weeks; ?allergy to research drugs; ?Pregnancy, breastfeeding or planning pregnancy; ? poor compliance with expectations.

Design outcomes

Primary

Measure	Time frame
Controlled attenuation parameter;	—

Secondary

Measure	Time frame
Liver function examination;Blood lipid examination;Glucose ;Serum insulin;HbA1c;Uric acid;Human Composition Analysis;BMI;TCM syndrome integral of damp-heat;CLDQ-NAFLD;	—

Countries

China

Contacts

Public ContactPeng Guo

Xiyuan Hospital of China Academy of Chinese Medical Sciences

763287580@qq.com+86 158 1032 7625

Outcome results

None listed

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