- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028077
Effects of GS-3K8 and GINst15 on Acute Respiratory Illness
January 18, 2017 updated by: Soo-Wan Chae, Chonbuk National University Hospital
The Efficacy and Safety of GS-3K8 and GINst15 on Acute Respiratory Illness in Healthy Subjects
This study was conducted to investigate the effects of daily supplementation of GS-3K8 or GINst15 on acute respiratory illness (ARI) in healthy subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jeollabuk-do
-
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
- Clinical Trial Center for Functional Foods Chonbuk National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
39 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo for 12 weeks
|
Placebo 1 g/day
|
Experimental: GS-3K8
GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks
|
GS-3K8 (ultrafiltered red ginseng extract) 1 g/day
|
Experimental: GINst15
GINst15 (6 cap/day, 500 mg/cap) for 12 weeks
|
GINst15 (hydrolyzed ginseng extract) 1 g/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
|
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
|
18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeong Hwan Hwang, M.D. Ph. D, Chonbuk National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
January 17, 2017
First Submitted That Met QC Criteria
January 18, 2017
First Posted (Estimate)
January 23, 2017
Study Record Updates
Last Update Posted (Estimate)
January 23, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTCF2_2014_GN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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