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Completed

NCT Number: NCT05725044

Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.

The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.

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Key information

Conditions

Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inha University Hospital

Incheon, South Korea

About this study

Previous studies have indicated that ginseng root may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ginsengberry concentrate on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine FSS(fatigue severity scale), CIS, lactate, Ammonia, Exercise test at baseline, as well as after 4 and 8 weeks of intervention. 88 adults were administered either ginsengberry concentrate or a placebo each day for 8 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CIS > 76 points

Exclusion criteria

  • A person who feels tired due to surgical operation within 6 months.
  • drug/alcoholic hepatitis, cirrhosis, and fatty liver
  • anorexia or bulimia
  • a person on night duty, shift work, or heavy redundancy
  • A person who is unable to perform an exercise load test
  • A person who implements professional exercise therapy, counseling therapy, etc. within two months of visit 1 to improve chronic fatigue.
  • A person who has used drugs, functional foods, health supplements, and herbal medicines within two months of visiting to improve chronic fatigue.
  • A person who continues to exercise regularly within three months of visiting
  • Immunosuppressants, sleep-inducing drugs, antidepressants, sleeping pills, and antihistamines

Treatment and study plan

Ginsengberry concentrate

Dietary Supplement

Ginsengberry concentrate

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. CIS

    Time frame: 8 weeks

    Checklist Individual Strength (20-item questionnaire, 1-7 Likert score, the minimum and maximum values is 20~140. Higher scores mean a worse outcome.)

  2. FSS

    Time frame: 8 weeks

    Fatigue severity Index (9-item questionnaire, 1-7 Likert scale, the minimum and maximum values is 9~63. Higher scores mean a worse outcome.)

  3. NRS

    Time frame: 8 weeks

    Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)

  4. Blood Indicators Related to Physical Fatigue

    Time frame: 8 weeks

    lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)

  5. Blood Indicators Related to Mental Fatigue

    Time frame: 8 weeks

    Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)

  6. exercise test

    Time frame: 8 weeks

    VO2max (ml/kg/min, maximal oxygen consumption)

Sponsors and collaborators

Lead sponsor

Amorepacific Corporation

Industry

Collaborators

  • Inha University Hospital

Registry information

Official study title

Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.

Acronym: fatigue

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 13, 2023
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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