The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health

NCT ID: NCT05182788

Last Updated: 2023-05-18

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-03-31

Brief Summary

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

Detailed Description

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

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo pressed candy

Group Type PLACEBO_COMPARATOR

Placebo pressed candy

Intervention Type DIETARY_SUPPLEMENT

consume 2 tablets per day for 8 weeks

CHOLESWISE pressed candy

Group Type EXPERIMENTAL

CHOLESWISE pressed candy

Intervention Type DIETARY_SUPPLEMENT

consume 2 tablets per day for 8 weeks

Interventions

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Placebo pressed candy

consume 2 tablets per day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

CHOLESWISE pressed candy

consume 2 tablets per day for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Natto combined Phyllanthus emblica pressed candy

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TCI Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Fengxian District Central Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2021-KY-24-01

Identifier Type: -

Identifier Source: org_study_id

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