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

NCT ID: NCT03028077

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GS-3K8

GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks

Group Type EXPERIMENTAL

GS-3K8

Intervention Type DIETARY_SUPPLEMENT

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

GINst15

GINst15 (6 cap/day, 500 mg/cap) for 12 weeks

Group Type EXPERIMENTAL

GINst15

Intervention Type DIETARY_SUPPLEMENT

GINst15 (hydrolyzed ginseng extract) 1 g/day

Placebo

Placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo 1 g/day

Interventions

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GS-3K8

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

Intervention Type DIETARY_SUPPLEMENT

GINst15

GINst15 (hydrolyzed ginseng extract) 1 g/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 1 g/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

39 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Principal investigator, Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Hwan Hwang, M.D. Ph. D

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CTCF2_2014_GN

Identifier Type: -

Identifier Source: org_study_id

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