Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05666752
Other study ID # NAS-IE-ON
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date September 2023

Study information

Verified date December 2022
Source Hanyang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement


Description:

This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 40 subjects were randomly divided into Allium Cepa L. Peel Heated Water Extract or a placebo group. Immunity Enhancement profiles before and after the intervention.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria: - Age 19-75 years - Symptoms of upper respiratory infection at least once within past 12 months Exclusion Criteria: - Cardio-cerebrovascular, endocrine, immune, respiratory, musculoskeletal, inflammatory, hematologic, tumorigenic, gastrointestinal diseases, etc. - Vaccination within past 2 months - BMI < 18.5 kg/m2 or 35 kg/m2 = BMI - Immunity enhancement agents within past one months - Allergic or hypersensitive to any of the ingredients in the test products - Antipsychotic drugs therapy within past 3 months - History of alcoholism or drug abuse - Participation in any other clinical trials within past 3 months - Pregnant or lactating women - Judged ineligible to participate in the trial by the principal investigator

Study Design


Intervention

Dietary Supplement:
Allium Cepa L. Peel Heated Water Extract
4 capsules/day after meal(1,200 mg/day) for 8 weeks
Placebo
4 capsules/day after meal(1,200 mg/day) for 8 weeks

Locations

Country Name City State
Korea, Republic of Hanyang University Seoul

Sponsors (1)

Lead Sponsor Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of Natural killer(NK) cell activity Changes of Natural killer(NK) cell activity will be assessed before and after the intervention.
PBMCs were isolated by density gradient separation, resuspended in phosphate-buffered saline, and determined using trypan blue solution. Natural killer(NK) cell activity was calculated from the results of nonradioactive cytotoxicity assay kits. Effector cells (PBMCs) were seeded in 96-well plates, with 50 ul of target cells (K562), incubated for 4 hours. cytotoxicity was calculated using the following formula: [(experimental-effector spontaneous-target spontaneous)/(target maximum-target spontaneous)]*100.
At week 0 and week 8
Secondary Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta) Changes of Cytokines(INF-gamma, IL-2, IL-6, IL-12, TNF-alpha, and IL-1beta) will be assessed before and after the intervention.
the serum levels of cytokines, including INF-gamma, IL-2, IL-6, IL-12, TNF-alpha, and IL-1beta will be measured.
At week 0 and week 8
Secondary Changes of Wisconsin Upper Respiratory Symptom Survey-21 Changes of Wisconsin Upper Respiratory Symptom Survey-21 will be assessed before and after the intervention At week 0 and week 4 and week 8
See also
  Status Clinical Trial Phase
Completed NCT03711292 - Using Behavioral Science to Reduce Inappropriate Antibiotic Use in Acute Care Settings N/A
Completed NCT01168778 - Improving Communication During Pediatric Visits for Acute Respiratory Illness N/A
Terminated NCT00187785 - Doctor-Patient Communication in Spanish N/A
Completed NCT00405509 - The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years N/A
Completed NCT00189475 - Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds Phase 4
Completed NCT04468204 - Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI) N/A
Completed NCT00255307 - Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection. Phase 2
Suspended NCT05035420 - A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases N/A
Recruiting NCT06244615 - Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat N/A
Completed NCT02694679 - Randomized Controlled Trial of Social Network Targeting in Honduras N/A
Completed NCT05352581 - BD Veritorâ„¢ At-Home and BD Veritorâ„¢ Professional
Active, not recruiting NCT02943551 - Dialogue Around Respiratory Illness Treatment N/A
Completed NCT01657643 - Effect of Probiotics on Health-related Quality of Life in College Students With Upper Respiratory Infections N/A
Completed NCT02110732 - Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil N/A
Completed NCT00694421 - Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 2 N/A
Completed NCT03884777 - Incidence and Risk of Influenza in Myasthenic Patients
Completed NCT00796315 - Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children Phase 1
Completed NCT00642681 - Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge Phase 2
Completed NCT00259831 - Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults Phase 3
Completed NCT04588376 - Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison N/A