Clinical study of metabolic associated fatty liver disease

A pragmatic randomized controlled clinical study of Tiaogan Huazhuo Decoction combined with exercise therapy in the treatment of metabolic associated fatty liver disease

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2022000064

Enrollment

Unknown

Registered

2022-06-24

Start date

2022-08-15

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

metabolic associated fatty liver disease

Interventions

treatment group:Tiaogan Huazhuo Decoction combined with exercise therapy

control group:exercise therapy

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria of Chinese and Western medicine for MAFLD; ? Between 18 and 65 years old; ? Those who have good compliance, are willing to participate in the study, complete all procedures and follow-up of the study, and sign informed consent.

Exclusion criteria

Exclusion criteria: ? Pregnant or lactating women; ? With serious diseases of important organs (such as heart, brain, lung and kidney); ? Clearly diagnosed as infectious hepatitis, liver biopsy has confirmed as cirrhosis, liver cancer patients; Or drug-induced liver disease, genetic factors and other specific diseases that can lead to fatty liver; (4) mentally and legally disabled patients; ? Suspected or had a history of drug abuse; Alcohol intake =40g/d for males and =20g/d for females; Or heavy drinking history within 2 weeks, equivalent to alcohol > 80g/d; ? Known to be allergic to the drug components; ? Exercise contraindications; ? Had used antibiotics, living bacteria preparations, hormone drugs, immunosuppressants and other preparations that may affect intestinal flora in the past 1 month; Or have used hypoglycemic, lipid-regulating and liver-protecting drugs in recent 1 month; ? Patients with ALT=3ULN or FPG=7.0mmol/L and no previous hypoglycemic drugs; ? Patients who are participating in clinical trials of other drugs; Or have participated in a drug clinical trial within the past one month.

Design outcomes

Primary

Measure	Time frame
controlled attenuation parameter;	—

Secondary

Measure	Time frame
Waist-Hip Ratio;blood lipids;TCM symptom score;liver stiffness measurement;blood pressure;Glycated hemoglobin;Body Mass Index;liver functions;Fasting blood sugar;uric acid;Intestinal microflora structure;Short Chain Fatty Acids;Highigh - sensitivity C - Reactive protein;Abdominal Ultrasound;	—

Countries

China

Contacts

Public ContactWang Shaoli

China Academy of traditional Chinese medicine Guang an Men hospital

drshaoliwang@163.com13466358638

Outcome results

None listed

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