Effect of WS-5 on the Mild Cognitive Impairment for the Efficacy and Safety; A 12week, multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003695

Enrollment

Registered

2019-04-01

Start date

2018-05-16

Completion date

Unknown

Last updated

2019-04-23

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 : Treatment(WS-5 940mg/ tablet) gourp: Take 1 tablet 2 times per day before or between meal for 12 weeks Control(placebo 940mg/ tablet) group: Take 1 tablet 2 times per day before o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult men and women aged from 55 t0 85 years old who complain memory loss 2) Those who can decipher Korean 3) CERAD-K memory score decreased from 1.0SD to less than 2.0SD compare to the same age and education level gruop (CERAD word list memory or word delayed recall or word recognition) 4) A person who agrees to participate in the test and has signed an informed consent form

Exclusion criteria

Exclusion criteria: 1) A person who is admitted to hospital with malignant tumor, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe heart disease (unstable angina, myocardial infarction, arrhythmia requiring heart failure treatment) or 3 months after discharge 2) According to DSM-V, a person with major depressive disorder or epidemic disease, or alcohol dependence 3) A person with disease causing cognitive impairment such as dementia, Parkinson's disease, etc. (The criteria for diagnosing dementia are based on DSM-V.) 4) A person who has experience of administering drugs (antipsychotic drugs, degenerative disease agents, brain function improvers, tricyclic antidepressants) for dementia or other cognitive dysfunction within 4 weeks 5) A person whose daily dose of vitamin E preparation is 400 IU or more, or whose dosage decreasing is inevitable. 6) A person who have received estrogen replacement therapy (excluding topical application agents) within 2 months of the start of the test 7) A person who took a healthy functional food related to improvement of cognitive function within 2 weeks 8) Patients with thyroid disease with TSH less than or equal to 0.1 uU / ml or greater than or equal to 10 uU / ml 9) A person whose creatinine level is more than twice the normal upper limit of the testing laboratory. 10) A person whose AST (GOT) or ALT (GPT) level is more than three times the normal upper limit of the testing laboratory. 11) Patients with uncontrolled hypertension (over 160 / 100mmHg, after 10 minutes of stabilization) 12) Diabetic patients whose blood sugar is not controlled (fasting blood sugar 180mg / dl or more) 13) A person who is pregnant, lactating or planning pregnant within 3 months. 14) A person who has participated in another clinical test within 3 months from the start of this test, or who plans to participate in another clinical test after the start of this test 15) Any person deemed inappropriate by the tester 16) A person with depression whose SGDS score is 8 or more

Design outcomes

Primary

Measure	Time frame
ADAS-cog(Alzheimer’s Disease Assessment Scale-cognitive sections) total score;ADAS cog(Noncognitive subscale of the ADAS) memory;ADAS-K(Alzheimer’s Disease Assessment Scale-Korean version);ADCS-ADL(Alzheimer’s Disease Cooperative Study-Activities of Daily Living)	—

Secondary

Measure	Time frame
Adverse Reactions;Clinical Laboratory;Vital Sign(Pulse, Blood Pressue), Weight;electrocardiogram	—

Countries

Korea, Republic of

Contacts

Public ContactMin joon

Chung-Ang Univerisity Hospital

whanam74@naver.com+82-2-6499-1521

Outcome results