A human trial to evaluate the efficacy and safety of Gastrodia elata Blume extract on improvement of Cognitive Function

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006605

Enrollment

100

Registered

2021-09-27

Start date

2021-09-10

Completion date

Unknown

Last updated

2023-01-10

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 : • Gastrodia elata Blume extract group: 1 times a day, 1 tablet once, after breakfast for 12 weeks(930 mg/day, 500 mg/day for Gastrodia elata Blume extract) • Placebo group: 1 tim

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged 45-65 years over at the screening examination 2) Participants who have mini mental state examination score of 20 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 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
ADAS-cog(Alzheimer’s Disease assessment Scale cognitive subscale)	—

Secondary

Measure	Time frame
K-MMSE(Korean Mini-Mental Status Examination);Brain-derived neurotrophic factor;Amyloid ß	—

Countries

Korea, Republic of

Contacts

Public ContactDong Gi Baek

Wonkwang University. Iksan Korean Medicine Hospital

Outcome results