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

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.

Study Overview

• Status: Unknown
• Conditions: Memory, Short-Term
• Intervention / Treatment: Dietary supplement: Polygoni Multiflori Radix complex extract; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeongsangnamdo
    • Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
      • Pusan National University Korean Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polygoni Multiflori Radix complex; Participants randomized to the experimental group will take one capsule of Polygoni Multiflori Radix complex extract (250mg) twice a day, 30 minutes after breakfast and dinner for 4 weeks.	Dietary supplement: Polygoni Multiflori Radix complex extract; Intervention is manufactured by Chun-Ho food
Placebo Comparator: Starch; Participants randomized to the placebo group will take one capsule of placebo(250mg) twice a day, 30 minutes after breakfast and dinner for 4 weeks.	Dietary supplement: Placebo; The placebo is filled with starch, so does not contain the active ingredient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Korean Medicine Hospital of Pusan National University
• Investigators: Study Chair: In Lee, Doctor, Pusan National University Korean Medicine Hospital; Principal Investigator: Hye-lim Park, Master, Pusan National University Korean Medicine Hospital; Principal Investigator: Eunhye Jeong, bachelor, National Clinical Research Center for Korean Medicine Pusan National University Korean Medicine Hospital; Principal Investigator: Hana Lee, bachelor, National Clinical Research Center for Korean Medicine Pusan National University Korean Medicine Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 25, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Memory_2015