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
About this trial
This is an interventional prevention trial for Chronic Stress-Induced Strain
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.
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
NCT ID
NCT03277833
First Posted
May 13, 2016
Last Updated
September 8, 2017
Sponsor
Chonbuk National University Hospital
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
Learn more about this trial
Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
We'll reach out to this number within 24 hrs