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Effects of HX106 on Improvement in Cognitive-Bio-Markers of Memory Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01956097
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : June 9, 2015
Last Update Posted : June 9, 2015
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Healthy Adults With Subjective Memory Complaints
Interventions: Dietary Supplement: HX106 590mg
Dietary Supplement: HX106 1180mg
Dietary Supplement: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HX106 590mg

HX106 590mg/day

HX106 590mg

HX106 1180mg

HX106 1180mg/day

HX106 1180mg

Placebo

Placebo

Placebo


Participant Flow:   Overall Study
    HX106 590mg   HX106 1180mg   Placebo
STARTED   30   30   15 
COMPLETED   24   28   15 
NOT COMPLETED   6   2   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HX106 590mg

HX106 590mg/day

HX106 590mg

HX106 1180mg

HX106 1180mg/day

HX106 1180mg

Placebo

Placebo

Placebo

Total Total of all reporting groups

Baseline Measures
   HX106 590mg   HX106 1180mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   15   75 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   30   30   15   75 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.6  (11.7)   42.5  (11.2)   40.6  (12.7)   40.1  (11.7) 
Gender 
[Units: Participants]
       
Female   18   17   4   39 
Male   12   13   11   36 
Region of Enrollment 
[Units: Participants]
       
Korea, Republic of   30   30   15   75 


  Outcome Measures

1.  Primary:   Changes From Baseline in Working Memory Domain Z-score   [ Time Frame: Baseline, 8th week ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 1st week ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 4th weeks ]

4.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 8th weeks ]

5.  Primary:   Changes From Baseline in White Matter Integrity Assessment   [ Time Frame: Baseline, 8th weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Soonhyun Ban, RN, MS
Organization: Ewha Brain Institute, Ewha W. University
phone: +82-2-3277-6550 ext 6554
e-mail: soonhyun.s.ban@gmail.com



Responsible Party: In Kyoon Lyoo, Ewha Womans University
ClinicalTrials.gov Identifier: NCT01956097     History of Changes
Other Study ID Numbers: HX106
First Submitted: September 26, 2013
First Posted: October 8, 2013
Results First Submitted: April 9, 2015
Results First Posted: June 9, 2015
Last Update Posted: June 9, 2015