Ginseng HRG80 in Stress and Fatigue

NCT ID: NCT03947554

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

HRG80 is an herbal preparation of Panax ginseng with a higher concentration of bioavailable ginsenosides than typical Korean ginseng. This study will test whether HRG80 is effective at preventing symptoms of stress, such as fatigue, impaired memory, difficulty in concentration, attention deficit, restlessness, and irritation related to daily work situations of healthy individuals in comparison to placebo and a standard Pananx ginseng with a lower concentration of ginsenosides.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychological Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HRG80 Panax ginseng

Panax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal.

Group Type EXPERIMENTAL

HRG80 Panax ginseng

Intervention Type DIETARY_SUPPLEMENT

Panax ginseng containing 63.4 mg ginsenosides

Panax ginseng

Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal.

Group Type ACTIVE_COMPARATOR

Panax ginseng

Intervention Type DIETARY_SUPPLEMENT

Panax ginseng containing 19.6 mg ginsenosides

Placebo

Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

800 mg excipient

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HRG80 Panax ginseng

Panax ginseng containing 63.4 mg ginsenosides

Intervention Type DIETARY_SUPPLEMENT

Panax ginseng

Panax ginseng containing 19.6 mg ginsenosides

Intervention Type DIETARY_SUPPLEMENT

Placebo

800 mg excipient

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Taking medicine or dietary supplements which may have potential effects on cognitive function
* Consuming more than 1 cup of coffee daily (in the morning).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Botalys SA

UNKNOWN

Sponsor Role collaborator

EuroPharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Areg Hovhannisyan, PhD, Dr Sci

Role: PRINCIPAL_INVESTIGATOR

Sports Medicine and Anti-Doping Service Republican Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sports Medicine and Anti-Doping Service Republican Centre

Yerevan, , Armenia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Armenia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EP-1005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Puerarin on Heart Health in Men
NCT03676296 COMPLETED PHASE2
Herbal Extract Study
NCT02095301 COMPLETED NA