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NCT05632341
GCWB1176 Evaluates the Effectiveness and Safety of Immune Function
Conditions: Immune Function
Sex: All
Ages: 19 Years – 75 Years
Phase: NA
Enrollment: 100
Sponsor: Green Cross Wellbeing
Location: Korea, Republic of
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:At the time of screening, 19 or 75 yearsA person with a peripheral blood leukocyte level measured in Visit 1, 3x10^3 cells/μl or more, 8x10^3 cells/μlThose who are more than one of the following standardsThose 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 visitThose who had Herpes Zoster infection within 1 year of visitThose with a stress awareness scale (PSS) 16 or moreA person who agrees to participate in this human application test before the start of the human test and writes a written consent formExclusion Criteria:Those who are currently treating drugs due to underlying disease, etc.Hypertension patients (systolic blood pressure 140 mmHg or higher or dichotomous blood pressure 90 mmHg or higher, human application test target 10 minutes stabilized)Patients with diabetes with an fasting blood sugar at least 126 mg/dL or administering urine disease (oral blood sugar, insulin, etc.)Those who are 0.1 UIU/mL or less, or 10 UIU/mL or moreThose who have vaccinated vaccines (influenza, corona, shingles that can affect immunity) within 3 months of visiting 1A disease that can affect immune responses such as adult -like and rhinitisAST (GOT) or ALT (GPT) is three times more than the normal upper limit of the embodimentThose who are 1.5 times more than the normal upper limit of CreatinineThose who administered steroids, antibiotics, immunosuppressants, and gastric acid inhibitors within 1 month of visit.Visit 1 person who consumes vitamins, health functional foods that can affect immunity within 2 weeks of visitingA 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.Those who complain of severe gastrointestinal symptoms such as heartburn and indigestionThose who are pregnant or have a planning plan for lactation or this human application periodThose 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 testThose who are sensitive or allergic to food ingredients for this human applicationThose who have a BMI (body mass index) of 30 kg/m2 or moreA person who consumed alcohol within 1 month (30 days) based on 1 visit (man> 210 g/week, woman> 140 g/week)Those who judge that the test person is inadequate for other reasons
Source: ClinicalTrials.gov (NCT05632341). StuddyBuddy aggregates publicly available trial information.