GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health

NCT05544942 | Completed

• 1 other identifier: GCWB109
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

This human application test was designed to evaluate the effectiveness and safety of the losing suction tendon, compared to the control food when the GCWB1001 was consistent with the symptoms of the respiratory symptoms of mildness.

Conditions

Respiratory Symptoms

Outcome Measures

Primary Outcomes (1)

• Change amoust of BCSS

  The comparison of the bcss change in the before and after the intake of the BCSS is analyzed using the Paired T-TEST, and the degree of change between the test group and the control group at each point of view is the Two Sample T-Test and the Wilcoxon Rank Sum test It is conducted to evaluate whether there is a significant difference.

  week -2, 6 and 12

Secondary Outcomes (4)

• Change amoust of Lung function (FVC, FEV1, FEV1/FVC)

  week -2, 6 and 12

• Change amoust of SGRQ

  week -2, 6 and 12

• Change amoust of VAS

  week -2, 6 and 12

• Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)

  week -2 and 12

Study Arms (2)

GCWB1001

EXPERIMENTAL

1 capsule once a day

Dietary Supplement: Lactobacillus plantarum

Placebo

ACTIVE COMPARATOR

1 capsule once a day

Other: maltodextrin

Interventions

Lactobacillus plantarum DIETARY_SUPPLEMENT

1 capsule once a day

GCWB1001

maltodextrin OTHER

1 capsule once a day

Placebo

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of screening, 19 or 70 years
• Those who have two or more symptoms of cough, sputum, lake striking or chest stuffy for more than one month, and BCSS at 3 or more
• Those with FEV 1 /FVC 70 or higher
• Those who agreed to participation in this human application test before the beginning of the human test and signed in the Informed Consent Form

You may not qualify if:

• Severe cardiovascular, immune system, gastrointestinal and biliary meters, kidney and urinary systems, Those who are currently treated with neurological system, musculoskeletal system, mental, infectious diseases and malignant tumors
• Those who have clinically significant respiratory diseases findings as a result of chest X-ray shooting
• Those who have been diagnosed with chronic obstructive pulmonary disease (COPD) or asthma
• Chronic bronchitis (BCSS 9 or more points or more Those who have continuous cough, sputum symptoms for more than 3 months)
• A person who has a respiratory symptom due to virus or bacteria within 4 weeks of visit (Influenza, Corona Virus infection 19, pneumonia, acute infection, etc.) However, if the corona virus infection 19 has worsened or new symptoms of respiratory symptoms occur (However, if there are no additional respiratory symptoms caused by corona-19 infections, you can participate after 4 weeks after isolation. In the case of additional respiratory symptoms, the symptoms improve and can be participated if they have been restored to the time of recovery so that there is no difference compared to before infection.)
• Those who take drugs for the purpose of taking immunosuppressive agents, or for the purpose of regulating Jinhae expectoration within 4 weeks of visit.
• Those who take health functional foods related to improvement of respiratory health within 2 weeks of visit 1
• Those who administered antibiotics within 2 weeks of visiting 1
• Probiotics and those who consistently consume lactic acid bacteria products (4 or more times a week) within 2 weeks
• Those who are less than 6 months after smokers or smoking cessation
• Less than 4 weeks of visit, a person who falls under alcohol with an average of 30 g (210 shares) per day (210 weeks), an average of 20 g or more (140 shares) per day (140 shares)
• Those who are more than twice the summit of Creatinine.
• AST (G OT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
• Inconsidable high blood pressure patients systolic blood pressure 160 mmHg or higher or relaxation blood pressure 100 mmHg or higher, test target 10 minutes stabilization
• Ungodined diabetic patient empathy 180 mg/dL or more

Sponsors & Collaborators

• Green Cross Wellbeing: lead

Study Sites (4)

HALLYM UNIV. Chuncheon MEDICAL CENTER

Chuncheon, South Korea

Location

Hallym Univ. Medical Center

Gyeonggi-do, South Korea

Location

Chungbuk national university hospital

Jungbuk, South Korea

Location

Hanyang University Seoul Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 19, 2022
• Study Start: August 23, 2022
• Primary Completion: August 30, 2023
• Study Completion: August 31, 2023
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

KR (4)