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

Not Applicable

Completed

• Conditions: Chronic Stress-Induced Strain
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)

• Registration Number: NCT03277833
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-04
• Study Completion: 2014-01
• Study First Submitted: 2016-05-13
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-08
• Last Update Submitted: 2017-09-08
• Study First Posted: 2017-09-11
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Gynostemma Pentaphyllum(Dungkulcha) Extract	Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)	Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)

Primary Outcome Measures

Name	Time	Method
Change in score of State&Trait version of STAI	Baseline and 8 weeks	Score of State\&Trait version of STAI was measured in study screening and visit 3(8 week).

Secondary Outcome Measures

Name	Time	Method
Change of Blood Norepinephrine Level	Baseline and 8 week	Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).
Change of Blood Cortisol Level	Baseline and 8 week	Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).
Change in score of Beck Anxiety Inventory	Baseline and 8 week	Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).