Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain

Study Overview
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Brief Summary
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The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.

Official Title
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Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain

Conditions
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Chronic Stress-Induced Strain

Intervention / Treatment
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* Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Age 20-65 years with chronic stress( S-STAI score 40 60) Exclusion Criteria: excessive physically chronic fatigue Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study Cardiovascular disease Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery Participation in any other clinical trials within past 2 months Renal disease Abnormal hepatic function Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study History of alcohol or substance abuse Pregnancy or lacting women etc.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gynostemma Pentaphyllum(Dungkulcha) Extract<br>Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d) | Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)<br>* Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design<br>|
| Placebo Comparator: Placebo<br>Placebo | Dietary Supplement: Placebo<br>* Placebo, parallel design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score of State&Trait version of STAI | Score of State&Trait version of STAI was measured in study screening and visit 3(8 week). | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Blood Norepinephrine Level | Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week). | Baseline and 8 week | 
| Change of Blood Cortisol Level | Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week). | Baseline and 8 week | 
| Change in score of Beck Anxiety Inventory | Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week). | Baseline and 8 week |