Cardiovascular DiseasesNCT04490720
The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
A study testing Buckwheat husk extract in people with Cardiovascular Diseases, run by TCI Co., Ltd. at 1 site in Taiwan.
Trial summary
To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Buckwheat husk extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Nov 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
- The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
- Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).
Who cannot join
- Pregnant women.
- People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
- No person has undergone major surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 114
chi fu chiang, Ph.D, Jimmy.Chiang@tci-bio.com
About this study
To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors
Read the detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.
- Conditions
- Cardiovascular Diseases
- Being tested
- Placebo, Buckwheat husk extract
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
consume 1 sachet per day for 2 months
Buckwheat husk extractDietary supplement
consume 1 sachet per day for 2 months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | consume 1 sachet per day for 2 months Receives: Dietary Supplement: Placebo |
| Buckwheat husk extract | Experimental | consume 1 sachet per day for 2 months Receives: Dietary Supplement: Buckwheat husk extract |
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
Secondary outcomes (4)
Change from baseline in Body Mass Index (BMI)
Body Mass Index (kg/m^2) will be measured at the beginning, 4-week, and 8-week time points.
P.S. weight in kilograms, height in meters
Measured: Days 1, 28, and 56
Change from baseline in waist-hip ratio
Waist-hip ratio 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 cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)
Blood cardiovascular disease risk biomarker will be measured at the beginning, 4-week, and 8-week time points.
Measured: Days 1, 28, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start24 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TCI Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mao-Hsin Lin, Doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490720
- Sponsor's protocol ID
- 201911003RSC
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2020
- Last updated
- 9 Jan 2025
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
- ClinicalTrials.gov ID
- NCT04490720
- Acronym / sponsor ID
- 201911003RSC
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TCI Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Jul 2020 (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 buckwheat husk extract on cardiovascular disease risk factors
Detailed description
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The clinical diagnosis item of cardiovascular disease is evaluated by the doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboconsume 1 sachet per day for 2 months |
| Buckwheat husk extract | Experimental | Dietary Supplement: Buckwheat husk extractconsume 1 sachet per day for 2 months |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
- The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
- Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- No history of organ transplantation, epilepsy or convulsions, liver or kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or other major organic diseases (according to medical history).
Key exclusion criteria (3 listed)
- Pregnant women.
- People with a history of organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
- No person has undergone major surgery.
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 |
|---|---|---|
| Placeboconsume 1 sachet per day for 2 months | Dietary supplement | Placebo |
| Buckwheat husk extractconsume 1 sachet per day for 2 months | Dietary supplement | Buckwheat husk extract |
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.
4 secondary outcomes
Change from baseline in Body Mass Index (BMI)
Time frame: Days 1, 28, and 56
Change from baseline in waist-hip ratio
Time frame: Days 1, 28, and 56
Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
Time frame: Days 1, 28, and 56
Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)
Time frame: Days 1, 28, and 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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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.
Mao-Hsin Lin, Doctor principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buckwheat husk extract in people with Cardiovascular Diseases, run by TCI Co., Ltd. at 1 site in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shyr-Chyr Chen ((02) 23123456, scchen@ntu.edu.tw), or a site near the patient. 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). 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 9 Jan 2025.