Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Cognitive Function

January 25, 2021 updated by: Young Chul Chung, Chonbuk National University Hospital

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Korea, Republic of, 54907
        • Department of Psychiatry, Chonbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrolysed Red Ginseng Extract
Hydrolysed Red Ginseng extract for 1g/day
once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 1g/day) for 12 week
PLACEBO_COMPARATOR: Placebo
Hydrolysed Red Ginseng extract for 0g/day
once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 0g/day) for 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual learning test
Time Frame: 12 weeks
Visual learning test was measured in baseline and 12 week.
12 weeks
Visual working memory test
Time Frame: 12 weeks
Visual working memory test was measured in baseline and 12 week.
12 weeks
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.

12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BDNF; Brain-derived neurotrophic factor
Time Frame: 12 weeks
Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.
12 weeks
Auditory continuous performance test
Time Frame: 12 weeks
Auditory continuous performance test was measured in baseline and 12 week.
12 weeks
Verbal learning test
Time Frame: 12 weeks
Verbal learning test was measured in baseline and 12 week.
12 weeks
PSS; Perceived stress scale
Time Frame: 12 weeks
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).
12 weeks
BDI; Beck Depression Inventory
Time Frame: 12 weeks
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.
12 weeks
TAS(Total antioxidant status)
Time Frame: 12 weeks
Total antioxidant status(TAS) was measured in baseline and 12 week.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

September 28, 2020

Study Completion (ACTUAL)

November 30, 2020

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

November 29, 2019

First Posted (ACTUAL)

December 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IH-CF-HRGE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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