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

TCI

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Buckwheat husk extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04490720

201911003RSC

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

consume 1 sachet per day for 2 months

Treatment:

Dietary Supplement: Placebo

Buckwheat husk extract

Experimental group

Description:

consume 1 sachet per day for 2 months

Treatment:

Dietary Supplement: Buckwheat husk extract