Clinical trial NCT02401646: Clinical Trials for the Effects of Polygoni Multiflori Radix Complex Extract on Memory Improvement
Official title: Clinical Trials for the Effects of Polygoni Multiflori Radix Complex Extract on Memory Improvement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Memory, Short-Term
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to identify the effect of Polygoni Multiflori Radix complex extract on memory improvement using Rey-Kim scale for healthy people.


Eligibility criteria: Inclusion Criteria:

* A person who is more than 50 years and lesser than 70 years of age
* A person who's MQ(Memory Quotient) score is within more than 70 and lesser than 120

Exclusion Criteria:

* The patient who has past history related to memory
* The patient who has Diabetes Mellitus
* The person whose fasting blood sugar is more than 126mg/dL
* The patients who has uncontrolled hypertension
* The patient who has liver disorders
* The patient whose AST(aspartate aminotransferase) or ALT(alanine aminotransferase) level is more than 60 IU/L(international units per liter)
* The patients who has heart disorders (Angina pectoris, Myocardial infarction)
* The patient who has past history related to excision of G-I tract excluding cecum
* The patient who took drug or heal functional food within 4 weeks before screening
* The patient who took decoction of herb within 4 weeks before screening
* The patient who can't write or communicate
* pregnant woman

Primary outcomes:
measure: Change from baseline on Memory Quotient score at 2 weeks and 4 weeks
timeFrame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement
Secondary outcomes:
measure: Change from baseline in Memory registration at 2 weeks and 4 weeks
timeFrame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement
measure: Change from baseline in Memory retention at 2 weeks and 4 weeks
timeFrame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement
measure: Change from baseline in Retrieval efficiency at 2 weeks and 4 weeks
timeFrame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement
measure: Change from baseline in Copy-recall difference index at 2 weeks and 4 weeks
timeFrame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Korean Medicine Hospital
state: Gyeongsangnamdo
Study officials:
affiliation: Pusan National University Korean Medicine Hospital
name: In Lee, Doctor
role: STUDY_CHAIR
affiliation: Pusan National University Korean Medicine Hospital
name: Hye-lim Park, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: National Clinical Research Center for Korean Medicine Pusan National University Korean Medicine Hospital
name: Eunhye Jeong, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: National Clinical Research Center for Korean Medicine Pusan National University Korean Medicine Hospital
name: Hana Lee, bachelor
role: PRINCIPAL_INVESTIGATOR
References: