Skip to content

Effect of Huoxue Jiedu optimize recipe on carotid atherosclerosis with hyperlipidaemia : A randomized double-blind placebo-controlled clinical trial

The clinical preparation study of Huoxue Jiedu optimized recipe in treating hyperlipidemia with carotid atherosclerosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000283
Enrollment
Unknown
Registered
2025-02-16
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

carotid atherosclerosis with hyperlipidemia

Interventions

Control group: Placebo of Huoxue Jiedu optimize recipe+Atorvastatin calcium tablets

Sponsors

Xiyuan Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) 40 years old = age =80 years old male or female are not limited; (2) Vascular ultrasound confirmed that it met the diagnostic criteria for carotid atherosclerosis carotid intimal thickness (IMT) = 1.0mm and carotid artery stenosis < 70% ; (3)Meet the diagnostic criteria for primary hyperlipidemia and meet any of the following: TC=5.2mmol/L; LDL-C=3.4mmol/L; TG=1.7mmol/L; (4)Traditional Chinese Medicine (TCM) syndrome differentiation belongs to the syndrome of blood stasis and toxin accumulation; (5)Not using lipid-lowering drugs/health products in the past 2 weeks; (6)Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Previously diagnosed coronary artery disease or comorbid uncontrolled hypertension (seated diastolic blood pressure =100 mmHg or systolic blood pressure =160 mmHg) or comorbid uncontrolled diabetes mellitus (glycated haemoglobin HbA1c =8.5%) or comorbid uncontrolled heart failure (NYHA classification =class III) and arrhythmias accompanied by clinical symptoms or haemodynamic disturbances; (2)Hyperlipidaemia induced by drugs (phenothiazines ß-blockers adrenocortical steroids and certain contraceptives etc.) or patients on hormones thyroxine therapeutics and other drugs affecting lipid metabolism; (3)Presence of a history of statin-associated liver damage and/or myopathy; (4)Patients with a combination of serious diseases of the lungs liver kidneys brain blood and other vital organs major infectious diseases severe metabolic/endocrine/electrolyte disorders active rheumatological-immunological disorders malignant tumours and psychiatric disorders (e.g. uncontrolled epilepsy depression mania schizophrenia etc); (5) Individuals who have experienced severe trauma or major surgery within the past six months, or have a tendency to bleed; (6) Pregnant and lactating women, as well as those planning to conceive within the past six months; (7) Individuals who are allergic to the experimental drug or its components; (8) Simultaneously participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Carotid Intima-Media Thickness;LDL-C;

Secondary

MeasureTime frame
TG;Brachial-ankle pulse conduction velocity;Carotid artery plaque area;TC;HDL-C;Integral of TCM Syndrome;

Countries

China

Contacts

Public ContactLizhi Li

Xiyuan Hospital Chinese Academy of Traditional Chinese Medicine

Lilizhi0723@163.com+86 18618403219

Outcome results

None listed

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