A human trial of fermented Aloe arborescens Miller extract on improvement of Cognitive Function

A 12 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of fermented Aloe arborescens Miller extract on improvement of Cognitive Function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007383

Enrollment

Registered

2022-06-14

Start date

2022-05-03

Completion date

Unknown

Last updated

2023-05-02

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 : • Aloe arborescens Miller extract group: twice a day, 2 capsules once, after breakfast/dinner, for 12 weeks (2.7 g/day) • Placebo group: twice a day, 2 capsules once, after breakf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Participants who have mini mental state examination score of 18 to 28. 2) 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. 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 are as follows. ? 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);PSS(Perceived stress scale);Brain-derived neurotrophic factor;BDI(Beck Depression Inventory)	—

Countries

Korea, Republic of

Contacts

Public Contactsoo jung Park

Woosuk University Korean Medicine Medical Center

taorgi@hanmail.net+82-63-220-8676

Outcome results