The Efficacy Evaluation of Buckwheat Husk Extract on Cardiovascular Disease Risk Factors

NCT ID: NCT04490720

Last Updated: 2025-01-09

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-24

Study Completion Date

2026-02-28

Brief Summary

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To assess the efficacy evaluation of buckwheat husk extract on cardiovascular disease risk factors

Detailed Description

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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

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

consume 1 sachet per day for 2 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Buckwheat husk extract

consume 1 sachet per day for 2 months

Group Type EXPERIMENTAL

Buckwheat husk extract

Intervention Type DIETARY_SUPPLEMENT

consume 1 sachet per day for 2 months

Interventions

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Placebo

consume 1 sachet per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

Buckwheat husk extract

consume 1 sachet per day for 2 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. 20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
2. The systolic blood pressure is 121-139 mmHg and the diastolic blood pressure is between 81-89 mmHg.
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. 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).

Exclusion Criteria

1. Pregnant women.
2. 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).
3. No person has undergone major surgery.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 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

Principal Investigators

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Mao-Hsin Lin, Doctor

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Shyr-Chyr Chen

Role: CONTACT

(02) 23123456

Facility Contacts

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chi fu chiang, Ph.D

Role: primary

Other Identifiers

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201911003RSC

Identifier Type: -

Identifier Source: org_study_id

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