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

A

Amorepacific

Status

Completed

Conditions

Fatigue

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Ginsengberry concentrate

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05725044
AP-PV-2021-01

Details and patient eligibility

About

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

Full 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.

Enrollment

88 patients

Sex

All

Ages

30 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

88 participants in 2 patient groups, including a placebo group

Ginsengberry concentrate
Experimental group
Description:
This group takes Ginsengberry concentrate for 8 weeks.
Treatment:
Dietary Supplement: Ginsengberry concentrate
Placebo
Placebo Comparator group
Description:
This group takes placebo for 8 weeks.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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