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

C

Chonbuk National University

Status

Completed

Conditions

Chronic Stress-Induced Strain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03277833
CBU-STR-DOLWOE

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 2 patient groups, including a placebo group

Gynostemma Pentaphyllum(Dungkulcha) Extract
Experimental group
Description:
Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)
Treatment:
Dietary Supplement: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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