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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03277833
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):
Soo-Wan Chae, 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.

Condition or disease Intervention/treatment Phase
Chronic Stress-Induced Strain Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day) Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
Study Start Date : March 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
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

Placebo Comparator: Placebo
Dietary Supplement: Placebo
Placebo, parallel design

Primary Outcome Measures :
  1. Change in score of State&Trait version of STAI [ Time Frame: Baseline and 8 weeks ]
    Score of State&Trait version of STAI was measured in study screening and visit 3(8 week).

Secondary Outcome Measures :
  1. Change of Blood Norepinephrine Level [ Time Frame: Baseline and 8 week ]
    Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).

  2. Change of Blood Cortisol Level [ Time Frame: Baseline and 8 week ]
    Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).

  3. Change in score of Beck Anxiety Inventory [ Time Frame: Baseline and 8 week ]
    Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Soo-Wan Chae, Principal Investigator, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital Identifier: NCT03277833    
Other Study ID Numbers: CBU-STR-DOLWOE
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sprains and Strains
Wounds and Injuries