Efficacy and safety evaluation of PPCE for immune enhancement in healthy adults.

Not Applicable

Completed

• Conditions: Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

• Registration Number: KCT0008678
• Lead Sponsor: MnF Korea

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-10-31
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

All research subjects participated in the human application test by satisfying the following criteria.
1) Adult men and women between the ages of 20 and 75 at the time of screening
2) A person who voluntarily decides to participate after listening to and fully understanding the detailed explanation of this study and agrees in writing to abide by the precautions.

Exclusion Criteria

Research subjects were excluded from participation in the human application test if any of the following criteria were me ;
1) A person whose WBC is less than 3000/µl or greater than 8000/µl in the screening test.
2) Subjects with a BMI of less than 18.5 kg/m2 at the time of screening
3) Those with a history of drug and clinically significant hypersensitivity reactions
4) Those with thyroid or pituitary disease
5) Those with acute severe cardiovascular disease such as renal failure, myocardial infarction, or stroke
6) Those who have or have a history of immune system disease or severe liver or kidney failure
7) Those who have or have a history of systemic diseases such as malignant tumors, lung diseases, leukemia, collagen disease, multiple sclerosis, allergic skin diseases and other autoimmune diseases
8) Those diagnosed with diabetes
9) Those with a history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of the product for human application test
10) A person who has experience of consuming medicines, herbal medicines, or health functional foods that can affect immunity within 2 weeks before the first intake of products for human application (in the case of health functional foods, after a one-week withdrawal period before the first intake) can participate)
11) Those who have received antipsychotic drug treatment within 2 months prior to screening
12) Those who have a history of treatment for alcoholism or drug abuse
13) Those who participated in other human application tests within 2 months before the screening test
14) A person who shows the following results in a laboratory test
? AST or ALT > twice the upper limit of the reference range
? Serum Creatinine > 2.0 mg/dl
15) Pregnant or lactating women
16) If women of childbearing potential do not accept proper contraception (except for women who have undergone sterilization)
17) A person who is judged unsuitable for participation in the study by the director of the study due to other reasons, including diagnostic test results.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ature Killer Cell activity

Secondary Outcome Measures

Name	Time	Method
Cytokine IL-6;Cytokine IL-12;Interferon-gamma; Upper Respiratory Symptom Survey