KCT0009424
Not yet recruiting
未知
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 enrollmentTBD
ConditionsDiseases of the respiratory system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the respiratory system
- Sponsor
- Jaein R&P
- Enrollment
- 120
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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
Outcomes
Primary Outcomes
Not specified
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