UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041041 |
|---|---|
| Receipt number | R000046846 |
| Scientific Title | The Effect of Nobiletin-rich Chinpi extract formulation on the sense of forgetfulness in healthy older adults. |
| Date of disclosure of the study information | 2020/07/09 |
| Last modified on | 2020/07/09 14:34:38 |
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Basic information
Public title
The Effect of Nobiletin-rich Chinpi extract formulation on the sense of forgetfulness in healthy older adults.
Acronym
ENCEF study
Scientific Title
The Effect of Nobiletin-rich Chinpi extract formulation on the sense of forgetfulness in healthy older adults.
Scientific Title:Acronym
ENCEF study
Region
| Japan |
Condition
Condition
Subjective cognitive impairment (SCI), Mild cognitive impairment (MCI)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the usefulness of nobiletin-rich Chinpi extract for sense of forgetfulness in the healthy elderly with subjective or mild cognitive impairment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in questionnaire about sense of forgetfulness (self-reported AD8) at the start of administration and after 24 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Active group takes nobiletin-rich Chinpi extract daily for 24 weeks. The dosage is 1pack = 1g, 3 times a day before each meal. They take 3 g/day of the extract formulation, which contains 1,800 mg of nobiletin-rich Chinpi.
Interventions/Control_2
Control group takes Chinpi extract daily for 24 weeks. The dosage is 1pack = 1g, 3 times a day before each meal. They take 3 g/day of the extract formulation, which contains 1,800 mg of Chinpi.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Subjective cognitive impairment or mild cognitive impairment.
(2) From 65 to 85 years old at the time of registration.
(3) Regardless of gender.
(4) Those who consent in writing to participate in this study.
(5) Those who have cooperation from information providers about his/her daily life for this study.
(6) Those who do not meet the exclusion criteria (see below).
Key exclusion criteria
(1) Already diagnosed with dementia or strongly suspected.
(2) Already diagnosed with a neurodegenerative disease (e.g. Parkinson's disease) or suspected by interview or medical examination.
(3) Affected to those physical condition by cerebrovascular disorders.
(4) Currently taking the following medications within 1 month.
･ Anti-dementia drug: donepezil, galantamine, rivastigmine (cholinesterase inhibitor) and memantine (NMDA receptor antagonist).
･Functional food and herbal medicines which claim that maintain cognitive function (e.g. phosphatidylserine, curcumin, ginkgo biloba extract and polygala root).
･Chinese herb preparations including Chinpi (e.g. Koso-san, Hei-san-san, Ni-chin-to, Tachibana-to, Tachibiki-to and Yokukan-san-Ken-saku).
･Central nervous system drugs (e.g. antidepressants, antipsychotics, anxiolytics, sleeping drugs, anti-parkinson drugs and psychostimulants).
(5) Suspected of having metabolic encephalopathy (e.g. hepatic encephalopathy, renal encephalopathy, electrolyte abnormality and chronic obstructive pulmonary disease) by interview or medical examination.
(6) Already diagnosed with mental illnesses (e.g. schizophrenia and depression) or suspected by an interview or examination.
(7) Judged by the research doctor to be inappropriate.
(8) An allergy history to Chinpi and citrus fruits.
(9) Metals in the body such as pacemaker.
(10) An allergy history to the FDG-PET tracer.
(11) Obvious liver dysfunction, renal dysfunction, heart failure, severe anemia, severe malnutrition and inflammatory reaction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Meguro |
Organization
New Industry Creation Hatchery Center (NICHe), Tohoku University
Division name
Geriatric Behavioral Neurology Project
Zip code
980-8575
Address
Institute of Development Aging and Cancer (IDAC), 4-1, Seiryo-machi, Aoba-ku, 980-8575 Sendai, Japan
TEL
+81-022-717-7359
k-meg@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomonari |
| Middle name | |
| Last name | Koto |
Organization
New Industry Creation Hatchery Center (NICHe), Tohoku University
Division name
Geriatric Behavioral Neurology Project
Zip code
980-8575
Address
Institute of Development Aging and Cancer (IDAC), 4-1, Seiryo-machi, Aoba-ku, 980-8575 Sendai, Japan
TEL
+81-022-717-7359
Homepage URL
tomonari.koto.b6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
New Industry Creation Hatchery Center (NICHe), Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Sendai Medical Imaging Clinic
2) Medical Imaging and Brain checkup Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Innovation and Education Center Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, 980-8574 Sendai, Miyagi, Japan
Tel
+81-22-717-7122
office@crieto.hosp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Sendai Medical Imaging Clinic (Miyagi Prefecture), Medical Imaging and Brain checkup Clinic (Miyagi Prefecture)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046846
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| Registered date | File name |
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