Ginseng HRG80 in Stress and Fatigue
Study of the Efficacy of Panax Ginseng Herbal Preparation HRG80 for Prevention and Mitigation of the Symptoms of Stress in Healthy Subjects
1 other identifier
interventional
50
1 country
1
Brief Summary
This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 5, 2019
May 1, 2019
3 months
May 9, 2019
July 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment
The Perceived Stress Scale is a psychological instrument for measuring the perception of stress by an individual. Scores from 0-13 indicate low stress, 14-26 is considered moderate stress, and scores from 27-40 indicate high perceived stress. The primary outcome is the change in the baseline PSS score for HRG80 versus standard Panax ginseng and placebo.
Two weeks
Study Arms (3)
HRG80 Panax ginseng
EXPERIMENTALPanax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal.
Panax ginseng
ACTIVE COMPARATORPanax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal.
Placebo
PLACEBO COMPARATORPlacebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal.
Interventions
Panax ginseng containing 63.4 mg ginsenosides
Eligibility Criteria
You may qualify if:
- Individuals experiencing at least one symptom of stress and fatigue during 8 hours of mental work with a computer.
- Men and women ages 18-65 (all races and ethnicities)
- Able to understand and participate in an 11-week study
You may not qualify if:
- Taking medicine or dietary supplements which may have potential effects on cognitive function
- Consuming more than 1 cup of coffee daily (in the morning).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EuroPharma, Inc.lead
- Botalys SAcollaborator
Study Sites (1)
Sports Medicine and Anti-Doping Service Republican Centre
Yerevan, Armenia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Areg Hovhannisyan, PhD, Dr Sci
Sports Medicine and Anti-Doping Service Republican Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 13, 2019
Study Start
April 1, 2019
Primary Completion
June 15, 2019
Study Completion
July 1, 2019
Last Updated
July 5, 2019
Record last verified: 2019-05