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

Study Overview
=================
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.

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

Conditions
-----------------
Acute Respiratory Infection

Intervention / Treatment
-----------------
* Dietary Supplement: GS-3K8
* Dietary Supplement: GINst15
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 39 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS-3K8<br>GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks | Dietary Supplement: GS-3K8<br>* GS-3K8 (ultrafiltered red ginseng extract) 1 g/day<br>|
| Experimental: GINst15<br>GINst15 (6 cap/day, 500 mg/cap) for 12 weeks | Dietary Supplement: GINst15<br>* GINst15 (hydrolyzed ginseng extract) 1 g/day<br>|
| Placebo Comparator: Placebo<br>Placebo for 12 weeks | Dietary Supplement: Placebo<br>* Placebo 1 g/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ultrafiltered red ginseng, hydrolyzed ginseng, acute respiratory illness, clinical trial