Efficacy and Safety of Xuezhikang Capsules in Treating MASLD with Hyperlipidemia: a Randomized Double-Blind Placebo-Controlled Multicenter Clinical Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025000512

Enrollment

Unknown

Registered

2025-03-13

Start date

2025-07-02

Completion date

Unknown

Last updated

2025-07-21

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 (MASLD) with hyperlipidemia

Interventions

Control group:Lifestyle intervention + Xuezhikang capsule placebo 0.6g twice daily

Experimental group:Lifestyle intervention + Xuezhikang Capsule 0.6g twice daily

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-65 years inclusive with no sex restriction; 2.Meeting diagnostic criteria for metabolic dysfunction-associated steatotic liver disease (MASLD) and hyperlipidemia; 3.Voluntary participation with signed written informed consent form.

Exclusion criteria

Exclusion criteria: The key exclusion criteria were as follows: (1) hepatic fibrosis or cirrhosis related to fatty liver (iLivTouch® liver stiffness measurement =9.7 kPa) other liver diseases affecting hepatic function (including alcoholic liver disease viral hepatitis drug-induced liver injury autoimmune hepatitis Wilson's disease or biliary obstruction) or history of liver/gallbladder surgery/interventions (e.g. hepatectomy liver ablation ERCP cholecystectomy); (2) excessive alcohol consumption within the past 6 months (average daily intake >15 g for females or >25 g for males or single-episode intake >40 g for females or >50 g for males); (3) impaired liver/kidney function (AST ALT GGT or ALP >2× upper limit of normal and/or eGFR [CKD-EPI formula] 2 weeks) of MASLD-inducing medications (e.g. amiodarone methotrexate glucocorticoids high-dose estrogen); (12) severe comorbidities (malignancy psychiatric/neurological disorders cardiovascular diseases requiring intervention or life expectancy <5 years); (13) pregnancy/lactation or planned pregnancy without contraception; (14) participation in other interventional trials within 3 months.

Design outcomes

Primary

Measure	Time frame
Liver Transient Elastography ;	—

Secondary

Measure	Time frame
LDL-C;TBIL;HOMA-IR;INS;FBG;eGFR;ALT;AST;ALP;TC;HDL-C;Scr;TG;HbA1c;GGT;	—

Countries

China

Contacts

Public ContactXiangyu Guo

Dongfang Hospital Beijing University of Chinese Medicine

gxyc1003@163.com17710397258

Outcome results

None listed

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