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

Cognitive Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184388
• Other study ID #: IH-CF-HRGE
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Chonbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2020
• Est. primary completion date: September 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Function

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Psychiatry, Chonbuk National University Hospital	Jeonju	Jeollabuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chonbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual learning test	Visual learning test was measured in baseline and 12 week.	12 weeks
Primary	Visual working memory test	Visual working memory test was measured in baseline and 12 week.	12 weeks
Primary	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	Auditory continuous performance test	Auditory continuous performance test was measured in baseline and 12 week.	12 weeks
Secondary	Verbal learning test	Verbal learning test was measured in baseline and 12 week.	12 weeks
Secondary	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).	12 weeks
Secondary	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.	12 weeks
Secondary	BDNF; Brain-derived neurotrophic factor	Brain-derived neurotrophic factor(BDNF)(pg/mL) was measured in baseline and 12 week.	12 weeks
Secondary	TAS(Total antioxidant status)	Total antioxidant status(TAS) was measured in baseline and 12 week.	12 weeks