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

Primary Purpose

Acute Respiratory Infection

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GS-3K8

GINst15

Placebo

About this trial

This is an interventional prevention trial for Acute Respiratory Infection focused on measuring ultrafiltered red ginseng, hydrolyzed ginseng, acute respiratory illness, clinical trial

Eligibility Criteria

39 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

GS-3K8

GINst15

Placebo

Arm Description

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

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

Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Incidence rate of ARI (by questionnaire)

Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.

Secondary Outcome Measures

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.

Duration of ARI symptoms (by questionnaire)

Duration of ARI symptoms were assessed before and after intervention

Full Information

NCT ID

NCT03028077

First Posted

January 17, 2017

Last Updated

January 18, 2017

Sponsor

Chonbuk National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03028077

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chonbuk National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Infection

Keywords

ultrafiltered red ginseng, hydrolyzed ginseng, acute respiratory illness, clinical trial

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GS-3K8

Arm Type

Experimental

Arm Description

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

Arm Title

GINst15

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for 12 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

GS-3K8

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

GINst15

Intervention Description

GINst15 (hydrolyzed ginseng extract) 1 g/day

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo 1 g/day

Primary Outcome Measure Information:

Title

Incidence rate of ARI (by questionnaire)

Description

Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.

Time Frame

18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Secondary Outcome Measure Information:

Title

Development of ARI symptoms (by questionnaire)

Description

Development of ARI symptoms (score) were assessed before and after intervention and followed up for 6 weeks after termination.

Time Frame

18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

Title

Duration of ARI symptoms (by questionnaire)

Description

Duration of ARI symptoms were assessed before and after intervention

Time Frame

18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

39 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeong Hwan Hwang, M.D. Ph. D

Organizational Affiliation

Chonbuk National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

City

Jeonju

State/Province

Jeollabuk-do

ZIP/Postal Code

560-822

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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