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

NCT ID: NCT03277833

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Gynostemma Pentaphyllum(Dungkulcha) Extract

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo, parallel design

Interventions

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

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo, parallel design

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chonbuk National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo-Wan Chae

Principal Investigator, Clinical Trial Center for Functional Foods

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CBU-STR-DOLWOE

Identifier Type: -

Identifier Source: org_study_id