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

NCT03277833 | Completed DMC

• 1 other identifier: CBU-STR-DOLWOE
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Stress-Induced Strain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Blood Norepinephrine Level

  Baseline and 8 week

• Change of Blood Cortisol Level

  Baseline and 8 week

• Change in score of Beck Anxiety Inventory

  Baseline and 8 week

Study Arms (2)

Gynostemma Pentaphyllum(Dungkulcha) Extract

EXPERIMENTAL

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

Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day) DIETARY_SUPPLEMENT

Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design

Gynostemma Pentaphyllum(Dungkulcha) Extract

Placebo DIETARY_SUPPLEMENT

Placebo, parallel design

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-65 years with chronic stress( S-STAI score 40\~60)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: September 11, 2017
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: January 1, 2014
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share