Clinical trial to evaluate the efficacy and safety of SH003 of immunity functio
- Conditions
- Diseases of the respiratory system
- Registration Number
- KCT0009424
- Lead Sponsor
- Jaein R&P
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 120
(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
(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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method atural killer cell
- Secondary Outcome Measures
Name Time Method Wisconsin Upper Respiratory Symptom Survey – 21