FatiguefatigueNCT05725044
Clinical Trial to Evaluate of Efficacy and Safety of Ginsengberry Concentrate on Fatigue.
A study testing Ginsengberry concentrate in people with Fatigue, run by Amorepacific Corporation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Ginsengberry concentrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2021to 3 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- CIS > 76 points
Who cannot join
- 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.
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.
The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Ginsengberry concentrate, Placebo
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginsengberry concentrateDietary supplement
Ginsengberry concentrate
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Ginsengberry concentrate | Experimental | This group takes Ginsengberry concentrate for 8 weeks. Receives: Dietary Supplement: Ginsengberry concentrate |
| Placebo | Placebo comparator | This group takes placebo for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 8 weeks
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.)
Measured: 8 weeks
NRS
Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)
Measured: 8 weeks
Blood Indicators Related to Physical Fatigue
lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Measured: 8 weeks
Blood Indicators Related to Mental Fatigue
Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Measured: 8 weeks
exercise test
VO2max (ml/kg/min, maximal oxygen consumption)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start13 Dec 2021
- Primary completion3 Mar 2023
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorepacific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inha University Hospital
- Responsible party
- Sponsor
- Investigators
- Kyung Lim Joa, Dr, Study director, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725044
- Sponsor's protocol ID
- AP-PV-2021-01
- Acronym
- fatigue
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Ginsengberry Concentrate on Fatigue: Randomized, Double-blind, and Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT05725044
- Acronym / sponsor ID
- fatigue / AP-PV-2021-01
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Amorepacific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Inha University Hospital
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators conduct a 8-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ginsengberry concentrate on fatigue.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginsengberry concentrate | Experimental | Dietary Supplement: Ginsengberry concentrateThis group takes Ginsengberry concentrate for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group takes placebo for 8 weeks. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CIS > 76 points
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginsengberry concentrateGinsengberry concentrate | Dietary supplement | Ginsengberry concentrate |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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.)
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.)
NRS
Time frame: 8 weeks
Numeric Rating Scale (for fatigue and Pain. 1-10 point scale. Higher scores mean a worse outcome.)
Blood Indicators Related to Physical Fatigue
Time frame: 8 weeks
lactic acid (mg/dL, Measurement before, immediately after, and after 30 minutes of exercise)
Blood Indicators Related to Mental Fatigue
Time frame: 8 weeks
Cortisol (㎍/dL, Measurement before, immediately after, and after 30 minutes of exercise)
exercise test
Time frame: 8 weeks
VO2max (ml/kg/min, maximal oxygen consumption)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Lim Joa, Dr study director
Inha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginsengberry concentrate in people with Fatigue, run by Amorepacific Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIS (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.