Clinical trial NCT05544942: GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health
Official title: GCWB1001 12 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Respiratory Health Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Symptoms
Lead sponsor: Green Cross Wellbeing
Sponsor class: INDUSTRY
First posted: 2022-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. At the time of screening, 19 or 70 years
2. 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
3. Those with FEV 1 /FVC 70 or higher
4. Those who agreed to participation in this human application test before the beginning of the human test and signed in the Informed Consent Form

Exclusion Criteria:

1. 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
2. Those who have clinically significant respiratory diseases findings as a result of chest X-ray shooting
3. Those who have been diagnosed with chronic obstructive pulmonary disease (COPD) or asthma
4. Chronic bronchitis (BCSS 9 or more points or more Those who have continuous cough, sputum symptoms for more than 3 months)
5. 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.)
6. Those who take drugs for the purpose of taking immunosuppressive agents, or for the purpose of regulating Jinhae expectoration within 4 weeks of visit.
7. Those who take health functional foods related to improvement of respiratory health within 2 weeks of visit 1
8. Those who administered antibiotics within 2 weeks of visiting 1
9. Probiotics and those who consistently consume lactic acid bacteria products (4 or more times a week) within 2 weeks
10. Those who are less than 6 months after smokers or smoking cessation
11. 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)
12. Those who are more than twice the summit of Creatinine.
13. AST (G OT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
14. 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
15. Ungodined diabetic patient empathy 180 mg/dL or more
16. Those who are pregnant or have a planning plan for lactation or this human application period
17. Those who have been administered to include other arbitral clinical trial applications within 3 months of visitor and have received food for adoption of drugs for clinical trials. Those who plan to participate
18. Those who are sensitive or allergic to food ingredients for this human application
19. Those who judge that the tester is inadequate for other reasons

Primary outcomes:
measure: Change amoust of BCSS
timeFrame: week -2, 6 and 12
Secondary outcomes:
measure: Change amoust of Lung function (FVC, FEV1, FEV1/FVC)
timeFrame: week -2, 6 and 12
measure: Change amoust of SGRQ
timeFrame: week -2, 6 and 12
measure: Change amoust of VAS
timeFrame: week -2, 6 and 12
measure: Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)
timeFrame: week -2 and 12
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: HALLYM UNIV. Chuncheon MEDICAL CENTER
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk national university hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym Univ. Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
References: