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

Sponsor
Amorepacific Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05725044
Collaborator
Inha University Hospital (Other)
88
1
2
23.7
3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ginsengberry concentrate
  • Dietary Supplement: Placebo
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.
Actual Study Start Date :
Dec 13, 2021
Anticipated Primary Completion Date :
Mar 3, 2023
Anticipated Study Completion Date :
Dec 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ginsengberry concentrate

This group takes Ginsengberry concentrate for 8 weeks.

Dietary Supplement: Ginsengberry concentrate
Ginsengberry concentrate

Placebo Comparator: Placebo

This group takes placebo for 8 weeks.

Dietary Supplement: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. CIS [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 [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 [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 [8 weeks]

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

  5. Blood Indicators Related to Mental Fatigue [8 weeks]

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

  6. exercise test [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inha University Hospital Incheon Korea, Republic of

Sponsors and Collaborators

  • Amorepacific Corporation
  • Inha University Hospital

Investigators

  • Study Director: Kyung Lim Joa, Dr, Inha University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amorepacific Corporation
ClinicalTrials.gov Identifier:
NCT05725044
Other Study ID Numbers:
  • AP-PV-2021-01
First Posted:
Feb 13, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 13, 2023