Chronic Stress-Induced Strain
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design
DIETARY_SUPPLEMENTPlacebo
Placebo, parallel design
Sponsors
Chonbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in score of State&Trait version of STAI | Baseline and 8 weeks | Score of State&Trait version of STAI was measured in study screening and visit 3(8 week). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Blood Norepinephrine Level | Baseline and 8 week | Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week). |
| Change of Blood Cortisol Level | Baseline and 8 week | Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week). |
| Change in score of Beck Anxiety Inventory | Baseline and 8 week | Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week). |
Outcome results
None listed