Memory, Short-TermPhase 4NCT02401646

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

A Phase 4 study testing Polygoni Multiflori Radix complex extract in people with Memory, Short-Term, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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. Read more about this study

Who is it for?: Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Memory, Short-Term
What is being tested?: Polygoni Multiflori Radix complex extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 1 siteSouth Korea
Study dates: Mar 2015to Dec 2015
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Pusan National University Korean Medicine Hospital
Yangsan, Gyeongsangnam-do, 626-770

Other trials in South Korea

About this study

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.

Conditions: Memory, Short-Term
Being tested: Polygoni Multiflori Radix complex extract, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polygoni Multiflori Radix complex extractDietary supplement
Intervention is manufactured by Chun-Ho food
PlaceboDietary supplement
The placebo is filled with starch, so does not contain the active ingredient.

Study groups in NCT02401646
Study group	Role	What they receive
Polygoni Multiflori Radix complex	Experimental	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. Receives: Dietary Supplement: Polygoni Multiflori Radix complex extract
Starch	Placebo comparator	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. Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline on Memory Quotient score at 2 weeks and 4 weeks
Measured: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, at 2 weeks after taking experimental or placebo dietary supplement, at 4 weeks after taking supplement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Dec 2015

First posted30 Mar 2015 (estimated)
Study startMar 2015
Primary completionNov 2015 (estimated)
Study completionDec 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Memory, Short-TermStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 54 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02401646
Sponsor's protocol ID: Memory_2015
Status last verified: Mar 2015
First submitted: 25 Feb 2015
Last updated: 30 Mar 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Memory, Short-Term trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trials for the Effects of Polygoni Multiflori Radix Complex Extract on Memory Improvement
ClinicalTrials.gov ID: NCT02401646
Acronym / sponsor ID: Memory_2015
Conditions: Memory, Short-Term
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 54 participants (estimated)
Lead sponsor: Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
Study start: Mar 2015
Primary completion: Nov 2015 (estimated)
Study completion: Dec 2015 (estimated)
First posted: 30 Mar 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Polygoni Multiflori Radix complex	Experimental	Dietary Supplement: Polygoni Multiflori Radix complex extractParticipants 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.
Starch	Placebo comparator	Dietary Supplement: PlaceboParticipants randomized to the placebo group will take one capsule of placebo(250mg) twice a day, 30 minutes after breakfast and dinner for 4 weeks.

Who may qualify

Ages: 50 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polygoni Multiflori Radix complex extractIntervention is manufactured by Chun-Ho food	Dietary supplement	Polygoni Multiflori Radix complex
PlaceboThe placebo is filled with starch, so does not contain the active ingredient.	Dietary supplement	Starch

Primary outcome

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

4 secondary outcomes

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
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
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
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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.

Related trials for Memory, Short-Term

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Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
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Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
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Cross-over Study on the Influence of Fampridine on Working Memory in Mild to Moderate Depression
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

In Lee, Doctor study chair

Pusan National University Korean Medicine Hospital

Hye-lim Park, Master principal investigator

Pusan National University Korean Medicine Hospital

Eunhye Jeong, bachelor principal investigator

National Clinical Research Center for Korean Medicine Pusan National University Korean Medicine Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Polygoni Multiflori Radix complex extract in people with Memory, Short-Term, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02401646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.