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Clinical Trials/KCT0009424
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional Study
Sex
All

Investigators

Sponsor
Jaein R&P

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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