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

Not Applicable

Completed

• Conditions: Acute Respiratory Infection
• Interventions: Dietary Supplement: GS-3K8; Dietary Supplement: GINst15; Dietary Supplement: Placebo

• Registration Number: NCT03028077
• Lead Sponsor: Chonbuk National University Hospital

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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS-3K8	GS-3K8	GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks
GINst15	GINst15	GINst15 (6 cap/day, 500 mg/cap) for 12 weeks
Placebo	Placebo	Placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of