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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: TCTR
Last refreshed on: 1 April 2024
Main ID:  TCTR20150914001
Date of registration: 14/09/2015
Prospective Registration: No
Primary sponsor: Agricultural Research Development Agency (Public Organization)
Public title: Effectiveness of Perilla oil with Mild to Moderate of Dementia Patient
Scientific title: Clinical Trial research
Date of first enrolment: 31/07/2014
Target sample size: 234
Recruitment status: Recruiting
URL:  https://www.thaiclinicaltrials.org/show/TCTR20150914001
Study type:  Interventional
Study design:  Randomized  
Phase:  Phase 2
Countries of recruitment
Thailand
Contacts
Name: Sombat    sombat rungrawee wongsa
Address:  Faculty of Medicine, Thammasat University 12120 Pathum Thani Thailand
Telephone: 086-999-4208
Email: sombatm@hotmail.com
Affiliation:  Faculty of Medicine, Thammasat University
Name: Somboon Lek   Keittinun
Address:  Chulabhorn International College of Medicine,Thammasat University 12120 Pathum Thani Thailand
Telephone: 025644440
Email: sbk9749@hotmail.com
Affiliation:  University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Male and female
2. Age >50 years
3. Screening Cog native scale using by Thai Mental State Examination (TMSE)
between 10-23 and MOCA 7-20
4. Diagnosed Dementia with mild to moderate follow by Diagnosis and Statistical
Manual of Mental Disorder, Fourth Edition (DSM-IV)
5. Can recognize and communicate
6. No have severe complications which cannot cooperate in this study
6.7 Volunteer be willing to participate in this study and conducts oneself follow by
suggestion duration in this study

Exclusion criteria: 1. Who is dementia can treatment for example dementia from kidney failure be
depleted Vitamin B12, liver abnormal, be decreased thyroid hormone,syphilis or
hypoglycemia Bleeding disorder or in take walfarine
2. Renal and liver function abnormal
3. Allergic of herbal medicine
4. Virulent congenital disease
5. Alcoholic and drugs addicted


Age minimum: 50 Years
Age maximum: 99 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Development of the medical and society led to population in the world are long life which rate of height birth in last time relate with be in move to aged elderly. Campaign for control the birth rate
Dementia,
alzheimer's disease,
Perilla frutescens (L.) Britton,
Omaga3,
Clinical Trial,
Randomize Control Trial,
Cognitive function,
MOCA
Dementia,
alzheimer's disease,
Perilla frutescens (L.) Britton,
Omaga3,
Clinical Trial,
Randomize Control Trial,
Cognitive function,
MOCA
Intervention(s)
Perilla Oil,Olive Oil
Perilla Oil which is a seed from plant in North of Thailand,Olive Oil is Extra Virgin Olive Oil.The oil that comes from the first "pressing" of the olive solely by mechanical or other physical means, and is extracted without using heat (a cold press) or chemicals
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Primary Outcome(s)
Effective of perilla oil with cog native score in Dementia patient mild to moderate 6 months TMSE,MOCA
Secondary Outcome(s)
Effective of perilla oil with activity in daily life in Dementia patient mild to moderate 6 months Modifile Barthel Index
Secondary ID(s)
Source(s) of Monetary Support
The human research ethic committee Thammasat University (No.2)
Secondary Sponsor(s)
Ethics review
Status: Submitted, approved
Approval date:
Contact:
benjawanjum@gmail.com
The human research ethic committee Thammasat University (No.2)
025644440 Ext. 1804
benjawanjum@gmail.com
Results
Results available:
Date Posted:
Date Completed: 31/10/2016
URL:
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