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

NCT04184388 | Completed

• 1 other identifier: IH-CF-HRGE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study was the evaluate the efficacy and safety of hydrolysed red ginseng extract on the improvement of Cognitive Function

Conditions

Cognitive Function

Keywords

Hydrolysed Red Ginseng Extract; Cognitive Function

Outcome Measures

Primary Outcomes (3)

• Visual learning test

  Visual learning test was measured in baseline and 12 week.

  12 weeks

• Visual working memory test

  Visual working memory test was measured in baseline and 12 week.

  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.

  12 weeks

Secondary Outcomes (6)

• Auditory continuous performance test

  12 weeks

• Verbal learning test

  12 weeks

• PSS; Perceived stress scale

  12 weeks

• BDI; Beck Depression Inventory

  12 weeks

• BDNF; Brain-derived neurotrophic factor

  12 weeks

Study Arms (2)

Hydrolysed Red Ginseng Extract

EXPERIMENTAL

Hydrolysed Red Ginseng extract for 1g/day

Dietary Supplement: Hydrolysed Red Ginseng Extract

Placebo

PLACEBO COMPARATOR

Hydrolysed Red Ginseng extract for 0g/day

Dietary Supplement: Placebo

Interventions

Hydrolysed Red Ginseng Extract DIETARY_SUPPLEMENT

once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 1g/day) for 12 week

Hydrolysed Red Ginseng Extract

Placebo DIETARY_SUPPLEMENT

once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 0g/day) for 12 week

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Study Officials

• Young-chul Chung, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 3, 2019
• Study Start: November 1, 2019
• Primary Completion: September 28, 2020
• Study Completion: November 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

KR (1)