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Effects of GS-3K8 and GINst15 on Acute Respiratory Illness

The Efficacy and Safety of GS-3K8 and GINst15 on Acute Respiratory Illness in Healthy Subjects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03028077
Enrollment
45
Registered
2017-01-23
Start date
2014-10-31
Completion date
2015-03-31
Last updated
2017-01-23

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

Conditions

Acute Respiratory Infection

Keywords

ultrafiltered red ginseng, hydrolyzed ginseng, acute respiratory illness, clinical trial

Brief summary

This study was conducted to investigate the effects of daily supplementation of GS-3K8 or GINst15 on acute respiratory illness (ARI) in healthy subjects.

Detailed description

This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15 (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the incidence of ARI. The secondary clinical outcome measure was the development and duration of ARI symptoms.

Interventions

DIETARY_SUPPLEMENTGS-3K8

GS-3K8 (ultrafiltered red ginseng extract) 1 g/day

DIETARY_SUPPLEMENTGINst15

GINst15 (hydrolyzed ginseng extract) 1 g/day

DIETARY_SUPPLEMENTPlacebo

Placebo 1 g/day

Sponsors

Chonbuk National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
39 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 39-65 years with healthy adults

Exclusion criteria

* Subjects had been vaccinated against influenza in the previous 6 months * Subjects with symptoms of upper respiratory tract infection * Subjects with acute/chronic disease * History of alcohol or substance abuse * History of disease that could interfere with the test products or impede their absorption * Subjects taking medications such as immune or upper respiratory tract infection related drug or functional foods * Abnormal liver or kidney function tests * Pregnant or lactating women and heavy smokers * Being judged by the responsible physician of the local study center as unfit to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Incidence rate of ARI (by questionnaire)18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.

Secondary

MeasureTime frameDescription
Development of ARI symptoms (by questionnaire)18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)Development of ARI symptoms (score) were assessed before and after intervention and followed up for 6 weeks after termination.
Duration of ARI symptoms (by questionnaire)18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)Duration of ARI symptoms were assessed before and after intervention

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026