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Completed

NCT Number: NCT03028077

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

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

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Key information

Conditions

Acute Respiratory Infection

Age range

39 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-3K8

Dietary Supplement

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

GINst15

Dietary Supplement

GINst15 (hydrolyzed ginseng extract) 1 g/day

Placebo

Dietary Supplement

Placebo 1 g/day

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Chonbuk National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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