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

Primary Purpose

Chronic Stress-Induced Strain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
Placebo
Sponsored by
Chonbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Stress-Induced Strain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Gynostemma Pentaphyllum(Dungkulcha) Extract

    Placebo

    Arm Description

    Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)

    Placebo

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Change of Blood Norepinephrine Level
    Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).
    Change of Blood Cortisol Level
    Blood cortisol level was measured in study visit 1(0 week) and visit 3(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).

    Full Information

    First Posted
    May 13, 2016
    Last Updated
    September 8, 2017
    Sponsor
    Chonbuk National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03277833
    Brief Title
    Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
    Official Title
    Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chonbuk National University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Stress-Induced Strain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gynostemma Pentaphyllum(Dungkulcha) Extract
    Arm Type
    Experimental
    Arm Description
    Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
    Intervention Description
    Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo, parallel design
    Primary Outcome Measure Information:
    Title
    Change in score of State&Trait version of STAI
    Description
    Score of State&Trait version of STAI was measured in study screening and visit 3(8 week).
    Time Frame
    Baseline and 8 weeks
    Secondary Outcome Measure Information:
    Title
    Change of Blood Norepinephrine Level
    Description
    Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).
    Time Frame
    Baseline and 8 week
    Title
    Change of Blood Cortisol Level
    Description
    Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).
    Time Frame
    Baseline and 8 week
    Title
    Change in score of Beck Anxiety Inventory
    Description
    Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).
    Time Frame
    Baseline and 8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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