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A 4 week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of NXP032 on Immune Function

A 4 week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of NXP032 on Immune Function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011534
Enrollment
120
Registered
2026-01-26
Start date
2022-11-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : The intervention group was divided into two groups based on whether or not they took the test food, NXP032 (vitamin C, Aptamin C320 complex). The test group took one tablet (36.05

Sponsors

NEXMOS
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those aged 19 years or older and 75 years or younger. 2) Those with a peripheral blood leukocyte count of 4x10^3 cells/µL or higher and less than 8x10^3 cells/µL as measured at Visit 1. 3) Those with a Perceived Stress Scale (PSS) score of 16 or higher. 4) Those who meet at least one of the following criteria: ? Those who have had two or more upper respiratory infections* within the year prior to Visit 1 *{Common Cold, acute tonsillitis, acute pharyngitis, acute laryngitis, acute rhinitis, etc.} ? Those who have had stomatitis two or more times within the year prior to Visit 1 ? Those who have had Herpes Zoster infection within the year prior to Visit 1 ? Those who have had three or more episodes of uncomplicated cystitis within the year prior to Visit 1 or two or more episodes of uncomplicated cystitis within the six months prior to Visit 1 ? Those who have experienced chronic fatigue symptoms (unexplained severe fatigue lasting more than three months, decreased concentration, memory loss, sleep disturbance, etc.) within the six months prior to Visit 1 5) A person who agrees to participate in the human application test and completes a written consent form (Informed Consent Form) before the human application test begins.

Exclusion criteria

Exclusion criteria: 1) Those currently receiving treatment for clinically significant acute or chronic cardiovascular, endocrine (e.g., thyroid disease), immune, respiratory, hepatobiliary, renal, urinary, nervous, musculoskeletal, psychiatric, infectious, hematological, or oncological diseases (however, participation in the study may be permitted at the discretion of the principal investigator, taking into account the subject's condition). 2) Hypertensive patients (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg, measured after 10 minutes of rest for human application test subjects). 3) Diabetic patients with a fasting blood sugar level =126 mg/dL or taking antidiabetic medication (oral hypoglycemic agents, insulin, etc.). 4) Those who have received any vaccines (e.g., influenza, coronavirus, shingles, etc.) within 3 months of Visit 1. 5) Those with diseases that may affect the immune response, such as adult asthma or rhinitis. 6) Those who have donated whole blood within two months of Visit 1 or have donated apheresis within four weeks. 7) Those with AST (GOT) or ALT (GPT) levels three times or more the upper limit of normal for the testing institution.

Design outcomes

Primary

MeasureTime frame
NK cell activity

Secondary

MeasureTime frame
Cytokines (IFN-?, TNF-a, IL-2, Granzyme A, Granzyme B, Perforin, Granulysin)

Countries

Korea, Republic of

Contacts

Public ContactJihyun Kim

NEXMOS

helen@nexmos.com+82-70-5138-0952

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 7, 2026