Study on cognitive function improvement and safety of plant pigment for the elderly with cognitive decline

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002798

Enrollment

Registered

2018-04-14

Start date

2014-10-22

Completion date

Unknown

Last updated

2019-03-11

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 : Participants were randomized to intervention or placebo group by computerized randomization. During 12 weeks, participants received 6 capsules once a day with water. Each capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Participants with no cognitive impairment on any CERAD-K scales and who scored 0 on the clinical dementia rating (CDR) score were (2) Participants who voluntarily attended this study (3) Participants who scored lower than a 7 on the Hamilton Rating Scale for Depression (HAM-D)

Exclusion criteria

Exclusion criteria: (1) Those included in DSM-IV criteria for dementia. (2) Patients with neurological or psychiatric disorders or those currently suffering from the disease (depression, schizophrenia, epilepsy, alcohol dependence, drug abuse or dependence). (3) Patients with heart disease (heart failure, angina, myocardial infarction), Patients with advanced arteriosclerosis. (4) Patients with malignant tumor or lung disease. (5) Patients with severe renal impairment (serum creatinin> 2.0 mg / dl). (6) Patients with severe hepatic dysfunction (> 2.5 times the upper limit of aspartate transaminase (AST) and alanine transaminase (ALT)and ALT bilirubin) (7) Patients with hypersensitivity to flavonoids. (8) Patients with a history of stroke or transient ischemic heart attack. (9) Those who have taking typical medicines to improve dementia and memory that may affect this clinical study. (10) Patients who currently participating in another clinical trial, or who have participated in a clinical trial within the past one month. (11) illiterate. (12) Patients who is judged to be unable to comply with the clinical trial according to the opinion of the this research director.

Design outcomes

Primary

Measure	Time frame
Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog);Korean version of the Consortium to Establish a Registry for Alzheimer’s disease (CERAD-K)	—

Secondary

Measure	Time frame
?? ?? ??	—

Countries

Korea, Republic of

Contacts

Public ContactSoo Hyun Joo

The Catholic University of Korea, Seoul St. Mary's Hospital

purple-sh@hanmail.net+82-2-2258-6081

Outcome results