Clinical trial NCT05632341: GCWB1176 Evaluates the Effectiveness and Safety of Immune Function
Official title: GCWB1176 8 Weeks, Multi -Tube, Randomized Assignment, Double -Eye, Placebo Control Human Application Test for Evaluating the Effectiveness and Safety of the Immune Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune Function
Lead sponsor: Green Cross Wellbeing
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
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 planned to evaluate the effectiveness and safety of immunodefinition compared to the placebo when the GCWB1176 was consumed for those whose white blood cell level was normal or somewhat decreased.


Eligibility criteria: Inclusion Criteria:

1. At the time of screening, 19 or 75 years
2. A person with a peripheral blood leukocyte level measured in Visit 1, 3x10\^3 cells/μl or more, 8x10\^3 cells/μl
3. Those who are more than one of the following standards

   * Those who had more than twice within one year of visiting 1 year.

     * {Common cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc.

       * Those who have stomatitis more than twice within 1 year of visit

         * Those who had Herpes Zoster infection within 1 year of visit
4. Those with a stress awareness scale (PSS) 16 or more
5. A person who agrees to participate in this human application test before the start of the human test and writes a written consent form

Exclusion Criteria:

1. Those who are currently treating drugs due to underlying disease, etc.
2. Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)
3. Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)
4. Those who are 0.1 UIU/mL or less, or 10 UIU/mL or more
5. Those who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1
6. A disease that can affect immune responses such as adult -like and rhinitis
7. AST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodiment
8. Those who are 1.5 times more than the normal upper limit of Creatinine
9. Those who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.
10. Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visiting
11. A person who has administered or consumed lactic acid bacteria products (4 or more times a week) within 2 weeks of visiting within 2 weeks of visit.
12. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
13. Those who are pregnant or have a planning plan for lactation or this human application period
14. Those who have participated in other interventional clinical trials (including human application test) within 8 weeks of visit, or plan to participate in other interventional clinical trials (including human application tests) after the beginning of this human application test
15. Those who are sensitive or allergic to food ingredients for this human application
16. Those who have a BMI (body mass index) of 30 kg/m2 or more
17. A person who consumed alcohol within 1 month (30 days) based on 1 visit (man\> 210 g/week, woman\> 140 g/week)
18. Those who judge that the test person is inadequate for other reasons

Primary outcomes:
measure: Change amoust of NK Cell Activity
timeFrame: week 0, 4 and 8
Secondary outcomes:
measure: Change amoust of Cytokine analysis (IFN-γ, TNF-α, IL-4, IL-10, IL-12)
timeFrame: week -2, 0, 4 and 8
measure: Change amoust of WBC Count analysis
timeFrame: week -2, 0, 4 and 8
measure: Change amoust of FSS Count analysis
timeFrame: week -2, 0, 4 and 8
measure: Change amoust of upper respiratory infection analysis
timeFrame: week -2, 0, 4 and 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, College of Medicine
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital, College of Medicine
Study officials:
References: