UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021115 |
|---|---|
| Receipt number | R000024367 |
| Scientific Title | Efficacy of ninjinyoeitou on cognitive dysfunction caused by intermittent carbon monoxide poisoning |
| Date of disclosure of the study information | 2016/02/20 |
| Last modified on | 2018/12/29 11:44:16 |
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Basic information
Public title
Efficacy of ninjinyoeitou on cognitive dysfunction caused by intermittent carbon monoxide poisoning
Acronym
Ninjinyoeitou for carbon monoxide poisoning
Scientific Title
Efficacy of ninjinyoeitou on cognitive dysfunction caused by intermittent carbon monoxide poisoning
Scientific Title:Acronym
Ninjinyoeitou for carbon monoxide poisoning
Region
| Japan |
Condition
Condition
intermittent carbon monoxide poisoning
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of ninjinyoeito on cognitive dysfunction caused by intermittent carbon monoxide poisoning
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FAB,MMSE, HDS-R
Before treatment, 1,2,4,6,8 weeks after starting treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ninjinyoeitou (2.5g)
3 packs per day, before each meal
for 8 weeks
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosed as intermittent carbon monoxide poisoning. Presenting with cognitive dysfunction or white matter lesion detected by head MRI
Key exclusion criteria
1. has been treated by other research drugs within the past three months
2. pregnant or possibly pregnant
3. breastfeeding
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Nishikawa |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5242
tnis.psyc@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Uezato |
Organization
Tokyo Medical and Dental University Graduate School
Division name
Department of Psychiatry and Behavioral Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5242
Homepage URL
uezato-tmd@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental Unversity
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024367
