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

Chonbuk National University Hospital45 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Acute Respiratory Infection

Interventions

GS-3K8DIETARY_SUPPLEMENT

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

GINst15DIETARY_SUPPLEMENT

GINst15 (hydrolyzed ginseng extract) 1 g/day

PlaceboDIETARY_SUPPLEMENT

Placebo 1 g/day

Eligibility

Sex: ALLMin age: 39 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Outcomes

Primary Outcomes

Incidence rate of ARI (by questionnaire)

Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.

Time frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Secondary Outcomes

Development of ARI symptoms (by questionnaire)

Development of ARI symptoms (score) were assessed before and after intervention and followed up for 6 weeks after termination.

Time frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Duration of ARI symptoms (by questionnaire)

Duration of ARI symptoms were assessed before and after intervention

Time frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Data from ClinicalTrials.gov

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