Effects of Bronch™ on Respiratory Health

Chonbuk National University

Status: Unknown

Conditions: Respiratory Health

Treatments: Dietary Supplement: placebo; Dietary Supplement: Bronch™

Study type: Interventional

Funder types: Other

Identifiers

NCT04812561

NS_Bronch_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Bronch™ group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Bronch™

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: placebo