Effects of Bronch™ on Respiratory Health

NCT ID: NCT04812561

Last Updated: 2021-03-23

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-14

Study Completion Date

2021-04-30

Brief Summary

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This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.

Detailed Description

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This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 60 subjects were randomly divided into Bronch™ group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking one pill twice a day, in comparison with taking a placebo.

Conditions

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Respiratory Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bronch™ group

2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day, 800 mg/day as Bronch™)

Group Type EXPERIMENTAL

Bronch™

Intervention Type DIETARY_SUPPLEMENT

2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week

Placebo group

2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week

Interventions

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Bronch™

2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week

Intervention Type DIETARY_SUPPLEMENT

placebo

2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Age 19-80 years at screening
* nonsmoker
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria

* Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Participants who have Body Mass Index(BMI) less than 18.5 kg/m\^2 or more than 35 kg/m\^2
* Participants who have taken medication or dietary supplements related to the respiratory disease within 1 months prior to screening
* Participants with a history of antipsychotic medication use within 3 months prior to the screening examination
* Participants who alcoholic or drug abuse suspected
* Participants who have participated in the other human trials within 3 months before the screening test
* Laboratory test by show the following results

* AST, ALT \> Reference range 3 times upper limit
* Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Wan Chae, Ph.D., M.D.

Role: CONTACT

82-63-259-3040

Facility Contacts

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Soo-Wan Chae, MD., PhD

Role: primary

82-63-259-3040

Other Identifiers

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NS_Bronch_01

Identifier Type: -

Identifier Source: org_study_id

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