None listed
Conditions
Interventions
Dietary Supplement : - Investigational product: SH003
- Placebo: The taste, aroma, and appearance will be similar to the investigational product.
- Method of administration: 8 weeks, twice a day, 2 ca
Sponsors
Jaein R&P
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adult men and women aged 19 years or older and 75 years or less at the time of screening test (2) Those who have had symptoms of upper respiratory infection (cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) more than twice within 12 months before the screening test (3) A person who, after hearing and fully understanding the detailed explanation of this clinical trial, voluntarily decides to participate and agrees in writing to comply with the precautions
Exclusion criteria
Exclusion criteria: (1) WBC less than 3000 /ml or greater than 8000 /ml on screening test (2) Immunizations (influenza, herpes zoster, pneumococcal, COVID-19, etc.) within 2 months prior to the date of first intake of the investigational product in humans (3) BMI less than 18.5 kg/m2 or greater than 35 kg/m2 at the time of the screening test (4) Taking medication for high blood pressure (5) Have a thyroid condition (6) Have medicated or uncontrolled diabetes (HbA1c > 7%) (7) Have clinically significant acute or chronic cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, musculoskeletal, inflammatory and hematologic/oncologic, or gastrointestinal disorders requiring medical treatment (8) Those who have taken medicines or dietary supplements related to immune function within one month prior to the screening test (9) Those with a history of significant hypersensitivity reactions to the ingredients (10) Those who have been treated with antipsychotic medication within 3 months prior to the screening test (11) Subjects with known or suspected alcoholism or drug abuse (12) Participation in another human clinical trial within 3 months prior to the screening test (13) Those with the following results in diagnostic medical tests AST, ALT > 3 times the upper limit of the reference range Serum Creatinine > 2.0 mg/dL (14) Pregnant or lactating women (15) Women of childbearing potential who are unwilling to accept adequate contraception (16) Those deemed unsuitable for participation in the study by the principal investigator for other reasons, including the results of diagnostic medical tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Natural killer cell | — |
Secondary
| Measure | Time frame |
|---|---|
| Wisconsin Upper Respiratory Symptom Survey – 21 | — |
Countries
Korea, Republic of
Contacts
Public ContactChunhoo Cheon
Kyung Hee University
Outcome results
None listed