Study on Hyperlipidemia Combined With Carotid Atherosclerosis With ShenJu Granules

NCT06166121 | Unknown

• 1 other identifier: YF2022-215
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Hyperlipidemia; Carotid Atherosclerosis

Keywords

Hyperlipidemia; Carotid arteriosclerosis; baPWV

Outcome Measures

Primary Outcomes (1)

• Arm and ankle pulse wave velocity

  Measures the degree of carotid artery sclerosis

  At enrollment versus at day 90

Secondary Outcomes (4)

• Blood glucose

  At enrollment versus at day 90

• Lipid indexes

  At enrollment versus at day 90

• Indicators of carotid atherosclerosis

  At enrollment versus at day 90

• TCM wet evidence

  At enrollment versus at day 90

Study Arms (2)

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

ShenJu OTHER

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

ShenJu

Placebo 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.)

placebo

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (2)

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

WangLei

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Hyperlipidemias; Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Lei Wang, M.D

CONTACT

8620-81887233-3280; Dr.wanglei@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: December 12, 2023
• Study Start: September 20, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)