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

NCT03028077 | Completed DMC

• 1 other identifier: CTCF2_2014_GN
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Development of ARI symptoms (by questionnaire)

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

• Duration of ARI symptoms (by questionnaire)

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

Study Arms (3)

GS-3K8

EXPERIMENTAL

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

Dietary Supplement: GS-3K8

GINst15

EXPERIMENTAL

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

Dietary Supplement: GINst15

Placebo

PLACEBO COMPARATOR

Placebo for 12 weeks

Dietary Supplement: Placebo

Interventions

GS-3K8 DIETARY_SUPPLEMENT

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

GS-3K8

GINst15 DIETARY_SUPPLEMENT

GINst15 (hydrolyzed ginseng extract) 1 g/day

GINst15

Placebo DIETARY_SUPPLEMENT

Placebo 1 g/day

Placebo

Eligibility Criteria

• Age: 39 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 39-65 years with healthy adults

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods Chonbuk National University Hospital

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

Location

Study Officials

• Jeong Hwan Hwang, M.D. Ph. D

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 23, 2017
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

KR (1)