Efficacy and safety of high Ginsenoside F1 extract on improvement of Cognitive Function

A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of high Ginsenoside F1 extract on improvement of Cognitive Function

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005509

Enrollment

120

Registered

2020-10-20

Start date

2020-06-24

Completion date

Unknown

Last updated

2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : - High Ginsenoside F1 extract group: twice a day, 1 capsule at a time, before breakfast or dinner, for 12 weeks (800 mg/day, 500 mg/day for high Ginsenoside F1 extract) - Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 60 years over at the screening examination 2) Participants who have mini mental state examination score of 25 to 28. 3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions.

Exclusion criteria

Exclusion criteria: 1) The patients who have a history of alcoholism or drug dependency/abuse within the last 3 months before the screening examination. 2) The patients who take medicine, health functional foods or oriental medicine within the last 1 month before the screening examination. 3) Patients who have participated in other clinical trials within the last 3 months before the screening examination. 4) Patients who have laboratory test outcomes as follow. ? AST(Aspartate aminotransferase), ALT(Alanine Transaminase) > three times the normal limit ? Serum Creatinine > 2.0 mg/dL 5) Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes.

Design outcomes

Primary

Measure	Time frame
Cognitive Function Test	—

Secondary

Measure	Time frame
Korean Version of the Montreal Cognitive Assessment;Perceived stress scale;Beck Depression Inventory;Brain-derived neurotrophic factor;Amyloid ß	—

Countries

Korea, Republic of

Contacts

Public ContactGi-Wook Kim

Jeonbuk National University Hospital

rehab-k26@daum.net+82-63-250-1810

Outcome results