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

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 Overview

• Status: Completed
• Conditions: Chronic Stress-Induced Strain
• Intervention / Treatment: Dietary supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Dietary supplement: Placebo; Placebo, parallel design
EXPERIMENTAL: Gynostemma Pentaphyllum(Dungkulcha) Extract; Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)	Dietary supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day); Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (ACTUAL): September 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: CBU-STR-DOLWOE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO