Study on Hyperlipidemia Combined With Carotid Atheroscler... | NCT06166121

Studies
Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

NCT06166121

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status

Unknown status

Last Update Posted

Dec 12, 2023Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Hyperlipidemia
Carotid Atherosclerosis

Interventions

ShenJu
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2023Actual

Primary Completion Date

Oct 30, 2023Actual

Completion Date

Dec 30, 2023Estimated

First Submitted Date

May 6, 2023

First Submission Date that Met QC Criteria

Dec 11, 2023

First Posted Date

Dec 12, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2023

Last Update Posted Date

Dec 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lei Wang,MD, Chief Physician, Guangdong Provincial Hospital of Traditional Chinese MedicinePrincipal Investigator

Lead Sponsor

Guangdong Provincial Hospital of Traditional Chinese MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ShenJu	Experimental	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
placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ShenJu	Other	One package per time, twice a day, 90 days of treatment	ShenJu

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Blood glucose	blood glucose in mmol/L	At enrollment versus at day 90
Lipid indexes	Total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, apolipoprotein (a), free fatty acids

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Wang, M.D	Contact	8620-81887233-3280		Dr.wanglei@139.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincial Hospital of Chinese Medicine	Recruiting	Guangzhou	Guangdong	510120	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias
D002340	Carotid Artery Diseases

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided