Effects of Bronch™ on Respiratory Health

A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health

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

Study Overview

• Status: Recruiting
• Conditions: Respiratory Health
• Intervention / Treatment: Dietary supplement: Bronch™; Dietary supplement: placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
      • Recruiting
      • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bronch™ group; 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™; 2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
Placebo Comparator: Placebo group; 2 times a day, 1 pill for 1 time, after breakfast/dinner meal(1,600 mg/day)	Dietary supplement: placebo; 2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FVC(Forced vital capacity)	The Forced vital capacity(FVC) was measured Flow rate discharged during the hard-working unit before and after the intervention.	screening, 12 week
FEV1(Forced expiratory volume in 1 second)	The Forced expiratory volume in 1 second(FEV1) was assessed before and after the intervention.	screening, 12 week

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 21, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 21, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Respiratory Health; licorice; Korean mint
• Other Study ID Numbers: NS_Bronch_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No