KCT0009424Not yet recruitingUnknown
A 8 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of SH003 of immunity function
Jaein R&P0 sites120 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 19(Year) to 75(Year) (—)
- Sex
- All
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
- •(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.
Investigators
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