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

Chronic Stress-Induced Strain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277833
• Other study ID #: CBU-STR-DOLWOE
• Status: Completed
• Phase: N/A
• First received: May 13, 2016
• Last updated: September 8, 2017
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: September 2017
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stress-Induced Strain
• Sprains and Strains

Intervention

Dietary Supplement:
• Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design
• Placebo
Placebo, parallel design

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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