Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

December 11, 2023 updated by: Lei Wang,MD, Guangdong Provincial Hospital of Traditional Chinese Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • WangLei
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ShenJu
On the basis of standardized drug treatment for Hyperlipidemia combined with carotid atherosclerosis, participants who met the inclusion criteria were randomly given ShenJu intervention on the day of inclusion, taking it twice a day for 90 days.
Other: ShenJu
One package per time, twice a day, 90 days of treatment
Placebo Comparator: placebo
On the basis of standardized drug treatment for Hyperlipidemia combined with carotid atherosclerosis, participants who met the inclusion criteria were randomly given placebo granules on the day of inclusion, which were taken twice a day for 90 days (the placebo was basically the same as ShenJu in terms of appearance, shape, color, taste, etc.)
Other: 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arm and ankle pulse wave velocity
Time Frame: At enrollment versus at day 90
Measures the degree of carotid artery sclerosis
At enrollment versus at day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood glucose
Time Frame: At enrollment versus at day 90
blood glucose in mmol/L
At enrollment versus at day 90
Lipid indexes
Time Frame: At enrollment versus at day 90
Total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, apolipoprotein (a), free fatty acids
At enrollment versus at day 90
Indicators of carotid atherosclerosis
Time Frame: At enrollment versus at day 90
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
TCM wet evidence
Time Frame: At enrollment versus at day 90
Whether it is in the population with phlegm and wetness
At enrollment versus at day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2023

Primary Completion (Actual)

October 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

December 11, 2023

First Posted (Estimated)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YF2022-215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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