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A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for evaluation of vascular endothelial function of White Ginseng Extract on Patients with risk of endothelial dysfunction

A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for evaluation of vascular endothelial function of White Ginseng Extract on Patients with risk of endothelial dysfunction

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029286
Enrollment
Unknown
Registered
2020-01-20
Start date
2019-09-10
Completion date
Unknown
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular disease

Interventions

Control group:placebo
Experimental group:White Ginseng Extract

Sponsors

Wuhan Xiangfang Specialist Clinical Pharmacology Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Men and women aged 40-75 years; 2. RHI 1.38 to 2; 3. The following items satisfy more than 1: (1) Fasting cholesterol (TC) >=5.2 mmol/L; (2) Fasting low-density lipoprotein cholesterol (LDL) >=3.4 mmol/L; (3) Fasting plasma glucose >=5.56 mmol/L; (4) Systolic blood pressure between 120-159 mmHg (including 159 mmHg); (5) BMI between 25 and 29.9 kg/m 2; (6) Waist-to-hip ratio (WHR) > 0.9 for men and > 0.85 for women. Waist circumference : The horizontal circumference through the center of the umbilicus, or the circumference of the midpoint line between the lowest point of the rib and the two horizontal lines at the upper edge of the iliac crest, measured with a flexible ruler, at the end of expiration and when inspiration does not begin. hip circumference: buttocks Horizontal circumference of the most prominent part posteriorly, measured with a flexible ruler); 4. Voluntary participation and signing of the informed consent form; 5. The subject is able to communicate well with the investigator and complete the study as specified in the protocol.

Exclusion criteria

Exclusion criteria: 1. Subjects with significantly impaired platelet function and platelet coagulation: i.e., platelet count (PLT) 500x10^9/L; or hematocrit (HCT) 30 kg/m2; 3. The diseases with abnormal clinical manifestations to be excluded, including but not limited to the severe cardiovascular and cerebrovascular system, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, inflammatory and hematological neoplastic diseases, gastrointestinal system diseases; 4. Subjects with a history of hypersensitivity to ginseng; 5. Subjects taking drugs, health products and traditional Chinese medicines related to platelet function, improving blood circulation and hyperlipidemia for 7 consecutive days within one month before screening; 6. Pregnant or lactating women or those who have a recent birth plan; 7. One or more clinically significant tests for hepatitis B surface antigen, hepatitis C antibody, HIV antigen-antibody, or Treponema pallidum antibody; 8. Other situations that the investigator considers inappropriate for participation in this trial; 9. Participated in other drug clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
reactive hyperemia index;

Secondary

MeasureTime frame
Endothelin-1;E-selectin;Pulse wave;Lipid metabolism index;Arterial stiffness index;Oxidized LDL;Total Antioxidant status;

Countries

China

Contacts

Public ContactWeiyong Li

Wuhan Xiangfang Specialist Clinic

2621239868@qq.com+86 027-88939389

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026