GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health
Primary Purpose
Respiratory Symptoms
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lactobacillus plantarum
maltodextrin
Sponsored by
About this trial
This is an interventional health services research trial for Respiratory Symptoms
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Those who are pregnant or have a planning plan for lactation or this human application period
- 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
- Those who are sensitive or allergic to food ingredients for this human application
- Those who judge that the tester is inadequate for other reasons
Sites / Locations
- HALLYM UNIV. Chuncheon MEDICAL CENTERRecruiting
- Chungbuk national university hospitalRecruiting
- Hallym Univ. Medical CenterRecruiting
- Hanyang University Seoul HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GCWB1001
Placebo
Arm Description
1 capsule once a day
1 capsule once a day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change amoust of Lung function (FVC, FEV1, FEV1/FVC)
The comparison of the Lung function (FVC, FEV1, FEV1/FVC) change in the before and after the intake of the Lung function (FVC, FEV1, FEV1/FVC) 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.
Change amoust of SGRQ
The comparison of the SGRQ change in the before and after the intake of the SGRQ 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.
Change amoust of VAS
The comparison of the VAS change in the before and after the intake of the VAS 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.
Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)
The comparison of the blood biomarker change in the before and after the intake of the blood biomarker 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.
Full Information
NCT ID
NCT05544942
First Posted
September 5, 2022
Last Updated
September 14, 2022
Sponsor
Green Cross Wellbeing
1. Study Identification
Unique Protocol Identification Number
NCT05544942
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Wellbeing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Symptoms
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GCWB1001
Arm Type
Experimental
Arm Description
1 capsule once a day
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
1 capsule once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum
Intervention Description
1 capsule once a day
Intervention Type
Other
Intervention Name(s)
maltodextrin
Intervention Description
1 capsule once a day
Primary Outcome Measure Information:
Title
Change amoust of BCSS
Description
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.
Time Frame
week -2, 6 and 12
Secondary Outcome Measure Information:
Title
Change amoust of Lung function (FVC, FEV1, FEV1/FVC)
Description
The comparison of the Lung function (FVC, FEV1, FEV1/FVC) change in the before and after the intake of the Lung function (FVC, FEV1, FEV1/FVC) 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.
Time Frame
week -2, 6 and 12
Title
Change amoust of SGRQ
Description
The comparison of the SGRQ change in the before and after the intake of the SGRQ 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.
Time Frame
week -2, 6 and 12
Title
Change amoust of VAS
Description
The comparison of the VAS change in the before and after the intake of the VAS 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.
Time Frame
week -2, 6 and 12
Title
Change amoust of blood biomarker (TNF-α, IgE, IL-6, IL-10, IFN-γ)
Description
The comparison of the blood biomarker change in the before and after the intake of the blood biomarker 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.
Time Frame
week -2 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Those who are pregnant or have a planning plan for lactation or this human application period
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
Those who are sensitive or allergic to food ingredients for this human application
Those who judge that the tester is inadequate for other reasons
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yeongmin Kwon
Phone
+82-70-8892-7881
Email
ymkwon@gccorp.com
Facility Information:
Facility Name
HALLYM UNIV. Chuncheon MEDICAL CENTER
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Youl Lee, Ph D
Facility Name
Chungbuk national university hospital
City
Chungbuk
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyu Kang, M.M.Sc
Facility Name
Hallym Univ. Medical Center
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong hee Choi, Ph. D
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Heon Kim, Ph D
12. IPD Sharing Statement
Learn more about this trial
GCWB1001 Evaluates the Effectiveness and Safety of Respiratory Health
We'll reach out to this number within 24 hrs