Clinical Trials for the Effects of Polygoni Multiflori Radix Complex Extract on Memory Improvement

Memory, Short-Term Clinical Trial

Official title:

Clinical Trials for the Effects of Polygoni Multiflori Radix Complex Extract on Memory Improvement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02401646
• Other study ID #: Memory_2015
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 25, 2015
• Last updated: March 24, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2015
• Source: Korean Medicine Hospital of Pusan National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Memory, Short-Term

Intervention

Dietary Supplement:
• Polygoni Multiflori Radix complex extract
Intervention is manufactured by Chun-Ho food
• Placebo
The placebo is filled with starch, so does not contain the active ingredient.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Korean Medicine Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Korean Medicine Hospital of Pusan National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on Memory Quotient score at 2 weeks and 4 weeks		baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement	Yes
Secondary	Change from baseline in Memory registration at 2 weeks and 4 weeks	Rey-Kim scale is a tool to assess the short-term memory. It is composed of AVLT and CFT.; # AVLT After tester speaks each 15 word, subjects are asked to tell all words immediately as memory serves. This process is repeated 5 times (Each process is called AVLT process 1-5 according to priority). After 20 minutes interval, subjects are also asked to tell all words they can remember (AVLT process 6). Right after that, subjects should select the words they heard among 35 words (AVLT process 7).; Memory registration is calculated by converting score difference into a percentage between AVLT process 1 and 5 mentioned above.	baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement	Yes
Secondary	Change from baseline in Memory retention at 2 weeks and 4 weeks	# AVLT After tester speaks each 15 word, subjects are asked to tell all words immediately as memory serves. This process is repeated 5 times (Each process is called AVLT process 1-5 according to priority). After 20 minutes interval, subjects are also asked to tell all words they can remember (AVLT process 6). Right after that, subjects should select the words they heard among 35 words (AVLT process 7).; Memory retention is calculated by converting score difference into a percentage between AVLT process 5 and 6 mentioned above.	baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement	Yes
Secondary	Change from baseline in Retrieval efficiency at 2 weeks and 4 weeks	# AVLT After tester speaks each 15 word, subjects are asked to tell all words immediately as memory serves. This process is repeated 5 times (Each process is called AVLT process 1-5 according to priority). After 20 minutes interval, subjects are also asked to tell all words they can remember (AVLT process 6). Right after that, subjects should select the words they heard among 35 words (AVLT process 7).; Retrieval efficiency is calculated by converting score difference into a percentage between AVLT process 6 and 7 mentioned above.	baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement	Yes
Secondary	Change from baseline in Copy-recall difference index at 2 weeks and 4 weeks	Rey-Kim scale is a tool to assess the short-term memory. It is composed of AVLT and CFT.; # CFT After tester shows subjects very complicated figure, subjects are asked to copy it (CFT process 1). Right after that, subjects should draw the figure as memory serves (CFT process 2). After 20 minutes interval, subjects are also asked to select the part of figure they copy among various figures (CFT process 3).; Copy-recall difference index is calculated by converting score difference into a percentage between CFT process 1 and 2 mentioned above.	baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement	Yes