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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06166121
Other study ID # YF2022-215
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 20, 2023
Est. completion date December 30, 2023

Study information

Verified date December 2023
Source Guangdong Provincial Hospital of Traditional Chinese Medicine
Contact Lei Wang, M.D
Phone 8620-81887233-3280
Email Dr.wanglei@139.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
ShenJu
One package per time, twice a day, 90 days of treatment
Placebo
One package per time, twice a day, 90 days of treatment (the placebo was basically the same as ShenJu in terms of appearance, shape, color, taste, etc.)

Locations

Country Name City State
China Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong
China WangLei Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arm and ankle pulse wave velocity Measures the degree of carotid artery sclerosis At enrollment versus at day 90
Secondary Blood glucose blood glucose in mmol/L At enrollment versus at day 90
Secondary Lipid indexes Total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, apolipoprotein (a), free fatty acids At enrollment versus at day 90
Secondary Indicators of carotid atherosclerosis IMT value, IMT rate of change, common carotid peak systolic flow rate (PSV), peak diastolic flow rate (EDV), pulsatile index (PI), resistance index (RI) At enrollment versus at day 90
Secondary TCM wet evidence Whether it is in the population with phlegm and wetness At enrollment versus at day 90
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