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

January 18, 2017 updated by: Soo-Wan Chae, Chonbuk National University Hospital

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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
        • Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

39 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 12 weeks
Placebo 1 g/day
Experimental: GS-3K8
GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks
GS-3K8 (ultrafiltered red ginseng extract) 1 g/day
Experimental: GINst15
GINst15 (6 cap/day, 500 mg/cap) for 12 weeks
GINst15 (hydrolyzed ginseng extract) 1 g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of ARI (by questionnaire)
Time Frame: 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.
18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of ARI symptoms (by questionnaire)
Time Frame: 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.
18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
Duration of ARI symptoms (by questionnaire)
Time Frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
Duration of ARI symptoms were assessed before and after intervention
18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jeong Hwan Hwang, M.D. Ph. D, Chonbuk National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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