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

Chonbuk National University Hospital72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Chronic Stress-Induced Strain

Interventions

Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)DIETARY_SUPPLEMENT

Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design

PlaceboDIETARY_SUPPLEMENT

Placebo, parallel design

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 8 weeks

Secondary Outcomes

Change of Blood Norepinephrine Level

Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).

Time frame: 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).

Time frame: 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).

Time frame: Baseline and 8 week

Data from ClinicalTrials.gov

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