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Clinical study on the lipid lowering effect of Rongqingbaohuashuan powder combined with atorvastatin in patients with hyperlipidemia

Clinical study on the lipid lowering effect of Rongqingbaohuashuan powder combined with atorvastatin in patients with hyperlipidemia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084632
Enrollment
Unknown
Registered
2024-05-21
Start date
2024-05-27
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Hyperlipidemia

Interventions

Control:Atorvastatin + placebo
Intervention:Rongqingbaohuashuan powder + atorvastatin

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: = 40 years old and = 75 years old, regardless of gender; 2. Carotid artery ultrasound showed unstable carotid atherosclerosis plaque; 3. Patients diagnosed with hyperlipidemia, after three months of lifestyle intervention, Low density lipoprotein cholesterol = 3.4mmol/L; 4. Screening for spatiotemporal abdominal triglycerides = 5.6mmol/L; 5. Hyperlipidemic patients who have not taken lipid-lowering drugs or are currently taking lipid-lowering drugs regularly are willing to discontinue their current lipid-lowering drugs for 2 weeks before taking atorvastatin medication.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic to any component of the investigational drug; 2. Patients with past or current clinical diagnosis of heart disease; 3. Patients with previous or current clinical diagnosis of cerebrovascular disease; 4. Patients with past or current clinical diagnosis of kidney disease; 5. Patients with previous or existing clinical diagnosis of diabetes; 6. Patients with previous or current clinical diagnosis of peripheral vascular disease; 7. Previously or currently clinically diagnosed as hypertensive patients; 8. Patients with severe liver disease (liver function alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin above the upper limit of normal values); 9. Creatine kinase (CK) is higher than the upper limit of normal value; 10. Rheumatoid and immune diseases, malignant tumors, etc; 11. Various acute and chronic infectious diseases and acute metabolic disorders.

Design outcomes

Primary

MeasureTime frame
Blood fat;

Secondary

MeasureTime frame
Carotid atherosclerotic plaque;HCY;Inflammatory factors;

Countries

China

Contacts

Public ContactCheng Mei

Qilu Hospital of Shandong University

jncm65@163.com+86 185 6008 2278

Outcome results

None listed

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