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

Fatigue Clinical Trial

— fatigue  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05725044
• Other study ID #: AP-PV-2021-01
• Status: Completed
• Phase: N/A
• Start date: December 13, 2021
• Est. completion date: May 3, 2023

Study information

• Verified date: January 2023
• Source: Amorepacific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Ginsengberry concentrate
Ginsengberry concentrate
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (2)

Lead Sponsor	Collaborator
Amorepacific Corporation	Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIS	Checklist Individual Strength (20-item questionnaire, 1-7 Likert score, the minimum and maximum values is 20~140. Higher scores mean a worse outcome.)	8 weeks
Primary	FSS	Fatigue severity Index (9-item questionnaire, 1-7 Likert scale, the minimum and maximum values is 9~63. Higher scores mean a worse outcome.)	8 weeks
Primary	NRS	Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)	8 weeks
Primary	Blood Indicators Related to Physical Fatigue	lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)	8 weeks
Primary	Blood Indicators Related to Mental Fatigue	Cortisol (?/dL, Measurement before, immediately after, and after 30 minutes of exercise)	8 weeks
Primary	exercise test	VO2max (ml/kg/min, maximal oxygen consumption)	8 weeks