GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health

NCT ID: NCT05544942

Last Updated: 2022-09-19

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GCWB1001

1 capsule once a day

Group Type EXPERIMENTAL

Lactobacillus plantarum

Intervention Type DIETARY_SUPPLEMENT

1 capsule once a day

Placebo

1 capsule once a day

Group Type ACTIVE_COMPARATOR

maltodextrin

Intervention Type OTHER

1 capsule once a day

Interventions

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Lactobacillus plantarum

1 capsule once a day

Intervention Type DIETARY_SUPPLEMENT

maltodextrin

1 capsule once a day

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Cross Wellbeing

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HALLYM UNIV. Chuncheon MEDICAL CENTER

Chuncheon, , South Korea

Site Status RECRUITING

Hallym Univ. Medical Center

Gyeonggi-do, , South Korea

Site Status RECRUITING

Chungbuk national university hospital

Jungbuk, , South Korea

Site Status RECRUITING

Hanyang University Seoul Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yeongmin Kwon

Role: CONTACT

+82-70-8892-7881

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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