Cognitive FunctionNCT04184388
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function
A study testing Hydrolysed Red Ginseng Extract in people with Cognitive Function, run by Chonbuk National University Hospital at 1 site in South Korea.
Trial summary
This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Hydrolysed Red Ginseng Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2019to 30 Nov 2020
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons who are at least 60 years of age at screening
- Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
- Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Who cannot join
- Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- Patients with BMI(Body Mass Index)<18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)
- Patients with alcohol abuse or dependence within the last 3 months
- Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- Patients with a history of clinically significant hypersensitivity to ginseng or red ginseng
- Patients taking medicines, health functional foods or herbal medicines related to the improvement of cognitive function and memory within 1 month before screening
Show all 13Show fewer
- Patients who ingested ginseng and red ginseng extract's health functional food within 1 month before screening
- Patients who whole blood donation within 1 months before the first ingestion or Component blood donation within 2 weeks
- Patients who participate in another human trial within 3 months
- Those who show the following results in the Laboratory test
- AST, ALT > 3 times upper limit of the normal range
- Other significant laboratory test opinion
- Patients who are deemed unsuitable for participating in the human trial due to other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Psychiatry, Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
About this study
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function
This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function
Read the detailed description
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 100 subjects participated in hydrolysed red ginseng extract or placebo group. To evaluate the changes in the evaluation items when hydrolysed red ginseng extract was taken 12 weeks compared with placebo.
- Conditions
- Cognitive Function
- Being tested
- Hydrolysed Red Ginseng Extract, Placebo
- Keywords
- Hydrolysed Red Ginseng Extract, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysed Red Ginseng ExtractDietary supplement
once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 1g/day) for 12 week
PlaceboDietary supplement
once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 0g/day) for 12 week
| Study group | Role | What they receive |
|---|---|---|
| Hydrolysed Red Ginseng Extract | Experimental | Hydrolysed Red Ginseng extract for 1g/day Receives: Dietary Supplement: Hydrolysed Red Ginseng Extract |
| Placebo | Placebo comparator | Hydrolysed Red Ginseng extract for 0g/day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual learning test
Visual learning test was measured in baseline and 12 week.
Measured: 12 weeks
Visual working memory test
Visual working memory test was measured in baseline and 12 week.
Measured: 12 weeks
MoCA-K; Korean Version of the Montreal Cognitive Assessment
Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation.
Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
Measured: 12 weeks
Secondary outcomes (6)
Auditory continuous performance test
Auditory continuous performance test was measured in baseline and 12 week.
Measured: 12 weeks
Verbal learning test
Verbal learning test was measured in baseline and 12 week.
Measured: 12 weeks
PSS; Perceived stress scale
Perceived stress scale(PSS) was measured in baseline and 12 week. It consists of 10 questions. Each question is evaluated from 0 (none) to 4 (very often), and 4 items (4, 5, 7, 8) are scored back and added to the remaining questions. The duration of the last month should be presented before implementation (if the duration is longer, the predictability is lowered).
Measured: 12 weeks
BDI; Beck Depression Inventory
Beck Depression Inventory(BDI) was measured in baseline and 12 week. It consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0~63 points for each question. Beck Depression Inventory(BDI) score is 0 ~ 9 points non-depression, 10 ~ 15 is mild depression, 16 ~ 23 is moderate depression, and 24 ~ 63 is severe depression.
Measured: 12 weeks
BDNF; Brain-derived neurotrophic factor
Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
Measured: 12 weeks
TAS(Total antioxidant status)
Total antioxidant status(TAS) was measured in baseline and 12 week.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Nov 2019
- Primary completion28 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Chul Chung, Chonbuk National University Hospital
- Investigators
- Young-chul Chung, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184388
- Sponsor's protocol ID
- IH-CF-HRGE
- Status last verified
- Jan 2021
- First submitted
- 29 Nov 2019
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function
- ClinicalTrials.gov ID
- NCT04184388
- Acronym / sponsor ID
- IH-CF-HRGE
- Conditions
- Cognitive Function
- Keywords
- Hydrolysed Red Ginseng Extract, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 3 Dec 2019 (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.
This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function
Detailed description
This study was 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate. 100 subjects participated in hydrolysed red ginseng extract or placebo group. To evaluate the changes in the evaluation items when hydrolysed red ginseng extract was taken 12 weeks compared with placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolysed Red Ginseng Extract | Experimental | Dietary Supplement: Hydrolysed Red Ginseng ExtractHydrolysed Red Ginseng extract for 1g/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboHydrolysed Red Ginseng extract for 0g/day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons who are at least 60 years of age at screening
- Persons who have Korean Mini-Mental Status Examination(K-MMSE) result in 25-28 points
- Persons who agree to voluntary participation and to comply with the Notice after fully hearing and understanding the details of this human trial
Key exclusion criteria (13 listed)
- Patients with a past history of treatment with Axis I disorder in SCID(Structured Clinical Interview for DSM-IV) which is a structured clinical interview in the Diagnostic and Statistical Manual of Mental Disorders at Screening or who have been treated within the last 3 years
- Patients with BMI(Body Mass Index)<18.5 kg/m^ or 35 kg/m^≤BMI(Body Mass Index)
- Patients with alcohol abuse or dependence within the last 3 months
- Patients who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.)
- Patients with a history of clinically significant hypersensitivity to ginseng or red ginseng
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 |
|---|---|---|
| Hydrolysed Red Ginseng Extractonce a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 1g/day) for 12 week | Dietary supplement | Hydrolysed Red Ginseng Extract |
| Placeboonce a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 0g/day) for 12 week | Dietary supplement | Placebo |
Primary outcome
Visual learning test
Time frame: 12 weeks
Visual learning test was measured in baseline and 12 week.
Visual working memory test
Time frame: 12 weeks
Visual working memory test was measured in baseline and 12 week.
MoCA-K; Korean Version of the Montreal Cognitive Assessment
Time frame: 12 weeks
Korean Version of the Montreal Cognitive Assessment(MoCA-K) was measured in baseline and 12 week. The cognitive function evaluation using the Montreal Cognitive Assessment(MoCA-K) is a total of 8 items, and evaluates cognitive functions such as time / execution power, vocabulary, memory, attention, sentence, abstraction, delayed recall, and orientation. Time / execution power's total score is 5 points, vocabulary's total score is 3 points, attention's total score is 3 points, sentence's total score is 3 points, abstraction's total score is 2 points, delayed recall's total score is 5 points, orientation's total score is 6 points. It takes about 10 minutes to complete, and the total score is 30 points and total score make sum score. A score of 23 points or more is regarded as normal. If you have less than 6 years of education, add 1 point.
6 secondary outcomes
Auditory continuous performance test
Time frame: 12 weeks
Verbal learning test
Time frame: 12 weeks
PSS; Perceived stress scale
Time frame: 12 weeks
BDI; Beck Depression Inventory
Time frame: 12 weeks
BDNF; Brain-derived neurotrophic factor
Time frame: 12 weeks
TAS(Total antioxidant status)
Time frame: 12 weeks
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 27 Jan 2021.
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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.
Young-chul Chung, MD principal investigator
Chonbuk National 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 Hydrolysed Red Ginseng Extract in people with Cognitive Function, run by Chonbuk National University Hospital 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 3 inclusion and 13 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 27 Jan 2021. 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?
Visual learning test (time frame: 12 weeks). The study lists 3 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 27 Jan 2021.