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

Acute Respiratory Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03028077
• Other study ID #: CTCF2_2014_GN
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: January 18, 2017
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• GS-3K8
GS-3K8 (ultrafiltered red ginseng extract) 1 g/day
• GINst15
GINst15 (hydrolyzed ginseng extract) 1 g/day
• Placebo
Placebo 1 g/day

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trial Center for Functional Foods Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of ARI (by questionnaire)	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	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.	18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
Secondary	Duration of ARI symptoms (by questionnaire)	Duration of ARI symptoms were assessed before and after intervention	18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)