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

March 24, 2015 updated by: Korean Medicine Hospital of Pusan National University
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 66 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline on Memory Quotient score at 2 weeks and 4 weeks
Time Frame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement
baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Memory registration at 2 weeks and 4 weeks
Time Frame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

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
Time Frame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

# 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
Time Frame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

# 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
Time Frame: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korean Medicine Hospital of Pusan National University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Memory_2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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