Cardiovascular DiseasesNCT05182788
The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health
A study testing CHOLESWISE pressed candy in people with Cardiovascular Diseases, run by TCI Co., Ltd. at 1 site in China.
Trial summary
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- CHOLESWISE pressed candy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
Read the detailed 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Placebo pressed candy, CHOLESWISE pressed candy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo pressed candyDietary supplement
consume 2 tablets per day for 8 weeks
CHOLESWISE pressed candyDietary supplement
Also called Natto combined Phyllanthus emblica pressed candy
consume 2 tablets per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo pressed candy | Placebo comparator | Not described Receives: Dietary Supplement: Placebo pressed candy |
| CHOLESWISE pressed candy | Experimental | Not described Receives: Dietary Supplement: CHOLESWISE pressed candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1, 28, and 56
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.
Measured: Days 1, 28, and 56
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.
Measured: Days 1, 28, and 56
Change from baseline in arteriosclerosis
Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.
Measured: Days 1 and 56
Secondary outcomes (2)
Change from baseline in blood glucose
Blood glucose will be measured at the beginning, 4-week, and 8-week time points.
Measured: Days 1, 28, and 56
Change from baseline in blood hs-CRP
Blood hs-CRP will be measured at the beginning 8-week time points.
Measured: Days 1 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start9 Jun 2022
- Primary completion30 Sep 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182788
- Sponsor's protocol ID
- 2021-KY-24-01
- Status last verified
- May 2023
- First submitted
- 4 Jan 2022
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Evaluation of CHOLESWISE Pressed Candy on Cardiovascular Health, a Single Center, Randomized, Doubld-Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT05182788
- Acronym / sponsor ID
- 2021-KY-24-01
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy evaluation of CHOLESWISE Pressed Candy on cardiovascular disease risk factors
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo pressed candy | Placebo comparator | Dietary Supplement: Placebo pressed candy |
| CHOLESWISE pressed candy | Experimental | Dietary Supplement: CHOLESWISE pressed candy |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo pressed candyconsume 2 tablets per day for 8 weeks | Dietary supplement | Placebo pressed candy |
| CHOLESWISE pressed candyAlso: Natto combined Phyllanthus emblica pressed candyconsume 2 tablets per day for 8 weeks | Dietary supplement | CHOLESWISE pressed candy |
Primary outcome
Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure)
Time frame: Days 1, 28, and 56
Blood pressure will be measured at the beginning, 4-week, and 8-week time points.
Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
Time frame: Days 1, 28, and 56
Blood lipid will be measured at the beginning, 4-week, and 8-week time points.
Change from baseline in blood coagulation factor (factor VII, fibrinogen)
Time frame: Days 1, 28, and 56
Blood coagulation factor will be measured at the beginning, 4-week, and 8-week time points.
Change from baseline in arteriosclerosis
Time frame: Days 1 and 56
Arteriosclerosis will be measured by B-scan ultrasonography at the beginning and 8-week time points.
2 secondary outcomes
Change from baseline in blood glucose
Time frame: Days 1, 28, and 56
Change from baseline in blood hs-CRP
Time frame: Days 1 and 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHOLESWISE pressed candy in people with Cardiovascular Diseases, run by TCI Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in blood pressure (systolic blood pressure, diastolic blood pressure) (time frame: Days 1, 28, and 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.