The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

Cardiovascular Diseases Clinical Trial

Official title:

The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182788
• Other study ID #: 2021-KY-24-01
• Status: Completed
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: TCI Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors

Description:

This is a single center, randomized, double-blind and placebo controlled study. Subjects are informed to consume the samples every day for 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Age = 30 years old, no gender limit;
• Patients with high blood pressure (systolic blood pressure> 120 mmHg or diastolic blood pressure> 80 mmHg) or high blood lipids (TC = 5.18 mmol/L or TG = 1.7 mmol/L), and no medication is used;
• Fully understand the purpose, benefits, potential risks and side effects of this research, and can objectively cooperate with doctors to complete the examination and assessment of diseases and physical conditions;
• People who voluntarily agree and sign an informed consent form.

Exclusion Criteria:

• People with a history of dyspepsia would affect the absorption of the test product;
• Any situation that may affect trial process, including difficult-to-control organic disease or infection, unstable angina pectoris, congestive heart failure and other severe disease;
• People with symptomatic and difficult-to-control neurological, mental diseases or mental disorders;
• Pregnant or breast-feeding women or women who have a positive result on a pregnancy test;
• Allergic to the components of the test product;
• Take supplementary foods and health supplements with the same efficacy two weeks before and during the test.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Placebo pressed candy
consume 2 tablets per day for 8 weeks
• CHOLESWISE pressed candy
consume 2 tablets per day for 8 weeks

Locations

Country	Name	City	State
China	Shanghai Fengxian District Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)	Blood pressure will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Primary	Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)	Blood lipid will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Primary	Change from baseline in blood coagulation factor (factor VII, fibrinogen)	Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Primary	Change from baseline in arteriosclerosis	Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.	Days 1 and 56
Secondary	Change from baseline in blood glucose	Blood glucose will be measured at the beginning, 4-week, and 8-week time points.	Days 1, 28, and 56
Secondary	Change from baseline in blood hs-CRP	Blood hs-CRP will be measured at the beginning 8-week time points.	Days 1 and 56