MedPath

A Study on the Effect of Food Containing Plant Extract on Blood pressure -A Randomized, Double-blind, Placebo-controlled Parallel group, Comparison Study

Not Applicable
Conditions
o
Registration Number
JPRN-UMIN000048172
Lead Sponsor
TOYO SHINYAKU Co., Ltd.
Brief Summary

Statistically significant difference was confirmed in the systolic blood pressure. Statistically significant difference was not confirmed in the diastolic blood pressure.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Subjects who have a history of and/or contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). (2) Subjects who contract chronic disease and are under treatment. (3)Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. (4) Subjects who have declared allergic reaction to ingredients of test foods. (5) Subjects who can't stop using medicines affecting blood pressure. (6)Subjects who can't stop using quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting blood pressure. (7) Subjects who have been pregnant or have a plan to become pregnant, or breast feed during the study period. (8) Subjects who have a history of and/or contract drug addiction and/or alcoholism. (9) Subjects who are shiftworker and/or midnight-shift worker. (10) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. (11) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath