Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

Hyperlipidemia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study of ShenJu in the Treatment of Hyperlipidemia Combined With Carotid Atherosclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06166121
• Other study ID #: YF2022-215
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

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