Skip to content

Study on Efficacy and Safety of Fermented Black Rice Bran Extract on Respiratory Health

A 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of BRB-F-S for respiratory health

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0009880
Enrollment
100
Registered
2024-10-25
Start date
2023-06-30
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged 19 to 75 years old at the time of screening test 2) Non-smokers (those who quit smoking three months before the start of the test) 3) A person who has two or more persistent respiratory discomfort symptoms (cough, sputum, dyspnea, or chest tightness) for more than one month and has 3 <= BCSS score <9

Exclusion criteria

Exclusion criteria: 1) A person who has been diagnosed or suspected of asthma and chronic respiratory diseases such as chronic obstructive pulmonary disease 2) A person who is contraindicated in pulmonary function tests (surgery within 3 months, respiratory infection, hemoptysis, etc.) or who are concerned about side effects caused by bronchodilators (tachycardia, arrhythmia, etc.) 3) A person who has a history of overreaction or clinically significant hypersensitivity to drugs and human body-applied test products. 4) A person who has a history of other cerebrovascular diseases, cardiovascular diseases, endocrine diseases, malignant tumors, immune system, nervous system, or biliary tract diseases and is deemed unable to participate in the research under the judgment of the person in charge of the examination. 5) A person who has been vaccinated with the COVID-19 vaccine within 8 weeks prior to the screening test or who is scheduled to be vaccinated during the period of ingestion of the human-applied test product (12 weeks) 6) A person who has received another vaccine (influenza vaccine, etc.) within 4 weeks prior to the screening test. 7) A person who has taken medicines (depressants, expectorants, steroids, antibiotics, etc.), herbal medicines, or health functional foods that may affect test results within four weeks from the screening test date. 8) A person with alcoholism, or drug abuse or dependence 9) A person with a history of gastrointestinal diseases(eg Crohn's disease, etc.) or gastrointestinal surgery(except for simple appendectomy or hernia surgery) that may affect the absorption of human-applied test products 10) A person who participated in another human body application test within three months prior to the screening test 11) Pregnant woman, lactating woman, or woman of childbearing age who does not have the will to accept adequate contraception during clinical trials (except for woman who has undergone infertility surgery) 12) A person who is deemed unsuitable to participate in the human body application test, due to the results of the Laboratory medicine examination and other reasons,

Design outcomes

Primary

MeasureTime frame
Breathless, Cough and Sputum scale;Lung function

Secondary

MeasureTime frame
Inflammation in bronchial tube

Countries

Korea, Republic of

Contacts

Public ContactMira Oh

Jeonbuk National University Hospital

mroh@jbctc.org+82-63-259-3050

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026