Clinical trial NCT06166121: Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules
Official title: A Randomized, Double-blind, Placebo-controlled Study of ShenJu in the Treatment of Hyperlipidemia Combined With Carotid Atherosclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperlipidemia
Carotid Atherosclerosis
Keywords: Hyperlipidemia
Carotid arteriosclerosis
baPWV
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focuses on PWV as the main outcome, aiming to evaluate the efficacy and safety of ShenJu in treating patients with hyperlipidemia combined with carotid atherosclerosis, and provide a basis for traditional Chinese medicine treatment of hyperlipidemia combined with carotid atherosclerosis.

Detailed description: Hyperlipidemia is very harmful and easy to cause atherosclerosis. Atherosclerosis is the main factor of carotid atherosclerosis. Carotid atherosclerosis and plaque are usually the characteristic manifestations of atherosclerosis. Carotid arteriosclerosis is closely related to stroke, and carotid arteriosclerosis, rupture and detachment of carotid plaques, carotid stenosis and occlusion can all lead to the occurrence of cerebrovascular events. Early detection and evaluation of hyperlipidemia with carotid atherosclerosis by various means can effectively reduce the risk of cardiovascular and cerebrovascular diseases. In order to better serve the vast number of patients, Professor Wang Lei has developed ShenJu granules based on traditional Chinese medicine prescriptions and years of clinical experience. Compared to decoction, ShenJu granules have a higher concentration, are more convenient to carry, and are easy to absorb. They have received unanimous praise from patients in clinical applications.

Eligibility criteria: Inclusion Criteria:

1. The patient has informed consent and signed the informed consent form
2. Age between 18-65 years old
3. Meet the diagnostic criteria for hyperlipidemia and accompanied by carotid arteriosclerosis
4. Meet the diagnostic criteria of TCM wet certificate: refer to the scoring standard of TCM Wet Disease Scale

Exclusion Criteria:

1. Severe liver, kidney and cardiac insufficiency
2. Any other serious disease or condition such as: malignant tumor, uncontrolled severe hypertension, diabetic ketoacidosis (acute complication/vascular abnormality), arrhythmia, coagulation abnormalities
3. Have participated in another clinical study within 30 days prior to enrollment or have received a history of randomized ketoacidosis in this study
4. Pregnant women, women preparing to become pregnant and lactating women
5. Patients who are allergic to relevant Chinese medicine ingredients
6. Patients who have had a stent inserted
7. Patients who the investigator determines are not suitable to participate in this study

Primary outcomes:
measure: Arm and ankle pulse wave velocity
timeFrame: At enrollment versus at day 90
Secondary outcomes:
measure: Blood glucose
timeFrame: At enrollment versus at day 90
measure: Lipid indexes
timeFrame: At enrollment versus at day 90
measure: Indicators of carotid atherosclerosis
timeFrame: At enrollment versus at day 90
measure: TCM wet evidence
timeFrame: At enrollment versus at day 90
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: WangLei
state: Guangdong
Study officials:
References: