UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of ninjinyoeitou on cognitive dysfunction caused by intermittent carbon monoxide poisoning
Title of the study (Brief title)	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	Toru Nishikawa
Organization	Tokyo Medical and Dental University Graduate School
Division name	Department of Psychiatry and Behavioral Sciences
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5242
Email	tnis.psyc@tmd.ac.jp

Public contact
Name of contact person	Akihito Uezato
Organization	Tokyo Medical and Dental University Graduate School
Division name	Department of Psychiatry and Behavioral Sciences
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5242
Homepage URL
Email	uezato-tmd@umin.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024367