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Clinical trial on the effectiveness and safety of Zanghongqu decoction piece in the treatment of hyperlipidemia

Clinical trial on the effectiveness and safety of Zanghongqu decoction piece in the treatment of hyperlipidemia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001724
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-09-30
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Hyperlipidemia

Interventions

Control group:Zanghongqu decoction piece placebo
Test group:Zanghongqu decoction piece

Sponsors

The First Affiliated Hospital of Henan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for hyperlipidemia and have LDL-C = 3.4 mmol/L; (2) Age between 18-75 years old gender is not limited; (3) Subjects were able to understand the purpose of the clinical trial participated voluntarily and signed informed consent.

Exclusion criteria

Exclusion criteria: Subjects shall be excluded from this trial if they meet any of the following criteria: (1) Persons with secondary dyslipidemia caused by disease or medication etc; (2) Those who are using heparin thyroid therapeutic drugs and other drugs that affect lipid metabolism; (3) Patients with familial refractory hyperlipidemia; (4) Those who have been taking statin drugs or lipid-lowering related Chinese medicines/proprietary Chinese medicines for a long period of time and cannot stop taking them; (5) History of cardiovascular and cerebrovascular diseases (coronary angina myocardial infarction heart failure stroke transient ischemic attack coronary artery revascularization or other arterial revascularization); (6) Patients with peripheral arterial disease or aortic aneurysm; (7) Patients with severe hypertension (SBP =180 and/or DBP =110) severe cardiac arrhythmia (rapid atrial fibrillation complete bundle branch block etc.) type 1 diabetes mellitus and type 2 diabetes mellitus; (8) Those with abnormal liver function (ALT/AST > 1.5 times the upper limit of reference value) and abnormal kidney function (Cr > upper limit of reference value); (9) Those suffering from malignant tumors organ failure post-transplantation and other serious chronic diseases; (10) Pregnant or lactating women or those who have a request for childbirth within 3 months; (11) Long-term alcoholism drug dependence or mental illness; (12) Those who are allergic to the drugs used in this study; (13) Poor compliance withdrawal serious organ damage acute and critical illnesses and infectious diseases; (14) Patients who have participated or are participating in other drug clinical studies within the last 3 months; (15) Patients who are judged by the investigator to be unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Mean percent change in LDL-C from baseline to week 12;

Secondary

MeasureTime frame
Mean percentage change in TG from baseline to week 4 and week 12;Mean percentage change in TC from baseline to week 4 and week 12;Mean percent change in LDL-C from baseline to week 4;Mean percentage change in blood homocysteine from baseline to weeks 4 and 12;Mean percent change in blood uric acid from baseline to weeks 4 and 12;The proportion of patients with LDL-C reduction =30% compared with baseline at 12 weeks of treatment;Mean percentage change in non-HDL-C from baseline to weeks 4 and 12;Mean percentage change in HDL-C from baseline to week 4 and week 12;Mean percent change in fasting insulin from baseline to weeks 4 and 12;Mean percent change in fasting glucose from baseline to weeks 4 and 12;

Countries

China

Contacts

Public ContactZhu Mingjun

The First Affiliated Hospital of Henan University of Chinese Medicine

zhumingjun317@163.com139038466672

Outcome results

None listed

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