NCT04812561

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 18, 2021

Last Update Submit

March 21, 2021

Conditions

Respiratory Health

Keywords

Respiratory HealthKorean mintlicorice

Outcome Measures

Primary Outcomes (2)

  • Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores

    CAT were measured in study screening, visit 2(6 week), visit 3(12 week). CAT was developed for use as a way to assess the quality of life of COPD patients, consisting of eight items, each of which evaluates 0 to 5 points, and the sum of all eight item scores is the CAT score. The best quality of life is 0 points, and the worst is 40 points.

    screening, 6, 12 week

  • Changes of BCSS(Breathlessness, Cough, and Sputum Scale) scores

    BCSS were measured in study visit 1(0 week), visit 2(6 week), visit 3(12 week). BCSS is a scale for evaluating symptoms of Breathlessness, cough, and sputum, which is a major symptom of COPD(Chronic obstructive pulmonary disease), and symptoms of Breathlessness, cough, and sputum are evaluated in five stages. \<Breathlessness, sputum\> 0: never, 1: rare, 2: occasionally, 3: often, 4: almost always \<Cough\> 0: never, 1: a little hard, 2: moderate extent of hard, 3: over moderate extent of hard, 4: serious hard

    0, 6, 12 week

Secondary Outcomes (2)

  • FVC(Forced vital capacity)

    screening, 12 week

  • FEV1(Forced expiratory volume in 1 second)

    screening, 12 week

Study Arms (2)

Bronch™ group

EXPERIMENTAL

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

Dietary Supplement: Bronch™

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

Bronch™DIETARY_SUPPLEMENT

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

Bronch™ group
placeboDIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

RECRUITING

Central Study Contacts

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

CONTACT

82-63-259-3040soowan@jbnu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Clinical Trial Center for Functional Foods

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 23, 2021

Study Start

December 14, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

KR(1)