Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

NCT ID: NCT06166121

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2023-12-30

Brief Summary

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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

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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.

Conditions

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Hyperlipidemia Carotid Atherosclerosis

Keywords

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Hyperlipidemia Carotid arteriosclerosis baPWV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

ShenJu

Intervention Type OTHER

One package per time, twice a day, 90 days of treatment

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.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.)

Interventions

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ShenJu

One package per time, twice a day, 90 days of treatment

Intervention Type 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.)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Lei Wang,MD

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Site Status RECRUITING

WangLei

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Wang, M.D

Role: CONTACT

Phone: 8620-81887233-3280

Email: [email protected]

Facility Contacts

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Lei Wang, M.D

Role: primary

Lei Wang, Doctor

Role: primary

Shuai Mao, Doctor

Role: backup

Other Identifiers

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YF2022-215

Identifier Type: -

Identifier Source: org_study_id