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

NCT02401646 | Unknown Phase 4 DMC

• 1 other identifier: Memory_2015
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory, Short-Term

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in Memory registration at 2 weeks and 4 weeks

  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

  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

  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

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

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Polygoni Multiflori Radix complex extract DIETARY_SUPPLEMENT

Intervention is manufactured by Chun-Ho food

Polygoni Multiflori Radix complex

Placebo DIETARY_SUPPLEMENT

The placebo is filled with starch, so does not contain the active ingredient.

Starch

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korean Medicine Hospital of Pusan National University: lead

Study Sites (1)

Pusan National University Korean Medicine Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Study Officials

• In Lee, Doctor

  Pusan National University Korean Medicine Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: March 30, 2015
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

KR (1)