GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health
NCT ID: NCT05544942
Last Updated: 2022-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2022-08-23
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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GCWB1001
1 capsule once a day
Lactobacillus plantarum
1 capsule once a day
Placebo
1 capsule once a day
maltodextrin
1 capsule once a day
Interventions
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Lactobacillus plantarum
1 capsule once a day
maltodextrin
1 capsule once a day
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
69 Years
ALL
No
Sponsors
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Green Cross Wellbeing
INDUSTRY
Responsible Party
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Locations
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HALLYM UNIV. Chuncheon MEDICAL CENTER
Chuncheon, , South Korea
Hallym Univ. Medical Center
Gyeonggi-do, , South Korea
Chungbuk national university hospital
Jungbuk, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Chang Youl Lee, Ph D
Role: primary
Jeong hee Choi, Ph. D
Role: primary
Mingyu Kang, M.M.Sc
Role: primary
Sang-Heon Kim, Ph D
Role: primary
Other Identifiers
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GCWB109
Identifier Type: -
Identifier Source: org_study_id
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