The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors
1 other identifier
interventional
60
1 country
1
Brief Summary
To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cardiovascular-diseases
Started Nov 2021
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedJanuary 9, 2025
January 1, 2025
4.1 years
July 26, 2020
January 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Change from baseline in Body Mass Index (BMI)
Days 1, 28, and 56
Change from baseline in waist-hip ratio
Days 1, 28, and 56
Change from baseline in blood lipid (total-Cholesterol, triglyceride, HDL-C, LDL-C)
Days 1, 28, and 56
Change from baseline in blood cardiovascular disease risk biomarker (hs-CRP, NO, Trimethylamine-N-oxide)
Days 1, 28, and 56
Study Arms (2)
Placebo
PLACEBO COMPARATORconsume 1 sachet per day for 2 months
Buckwheat husk extract
EXPERIMENTALconsume 1 sachet per day for 2 months
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TCI Co., Ltd.lead
Study Sites (1)
National Taiwan University Hospital
Taipei, 114, Taiwan
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Mao-Hsin Lin, Doctor
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2020
First Posted
July 29, 2020
Study Start
November 24, 2021
Primary Completion
December 31, 2025
Study Completion
February 28, 2026
Last Updated
January 9, 2025
Record last verified: 2025-01