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

Sponsor
Chonbuk National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03028077
Collaborator
(none)
45
Enrollment
1
Location
3
Arms
5
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: GS-3K8
  • Dietary Supplement: GINst15
  • Dietary Supplement: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
The Efficacy and Safety of GS-3K8 and GINst15 on Acute Respiratory Illness in Healthy Subjects
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: GS-3K8

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

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

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

Dietary Supplement: GINst15
GINst15 (hydrolyzed ginseng extract) 1 g/day
Placebo Comparator: Placebo

Placebo for 12 weeks

Dietary Supplement: Placebo
Placebo 1 g/day

Outcome Measures

Primary Outcome Measures

  1. Incidence rate of ARI (by questionnaire) [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 Outcome Measures

  1. Development of ARI symptoms (by questionnaire) [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) [18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)]

    Duration of ARI symptoms were assessed before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
39 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Trial Center for Functional Foods Chonbuk National University Hospital Jeonju Jeollabuk-do Korea, Republic of 560-822

Sponsors and Collaborators

  • Chonbuk National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Soo-Wan Chae, Principal investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT03028077
Other Study ID Numbers:
  • CTCF2_2014_GN
First Posted:
Jan 23, 2017
Last Update Posted:
Jan 23, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Soo-Wan Chae, Principal investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ultrafiltered red ginseng
hydrolyzed ginseng
acute respiratory illness
clinical trial
Additional relevant MeSH terms:
Respiratory Tract Infections

Study Results

No Results Posted as of Jan 23, 2017