臨床研究等提出・公開システム

Scientific Title	A before-after study on the safety and nutritional status improvement after L-arginine hydrochloride intervention in patients with amyotrophic lateral sclerosis
Public Title	Study on the safety and nutritional status improvement of L-arginine hydrochloride intervention for ALS

Contact for Scientific Queries	Name	Horofumi Maruyama
	Affiliation	Hiroshima University Hospital
	Address	1-2-3, Kasumi, Minami-ku, Hiroshima
	Telephone	+81-82-257-5201
	E-mail	hmaru@hiroshima-u.ac.jp
Contact for Public Queries	Name	Hiroyuki Naito
	Affiliation	Hiroshima Univetrsity Hospital
	Address	1-2-3, Kasumi, Minami-ku, Hiroshima
	Telephone	+81-82-257-5201
	E-mail	hi-naito@outlook.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 11, 2023
Actual date of first enrollment
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Diagnosed as ALS by Gold Coast criteria Patients visiting or admitted in our hospital, and can be followed up more than 3 months
	Exclusion Criteria	Arginase deficiency Lysineuric protein intolerance whose absorption inhibition of L-arginine hydrochloride is great in degree Taking Argi-U Using ventilator Scheduled for surgery at the time of registration
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Amyotrophic lateral sclerosis
Intervention(s)		Taking L-arginine hydrochloride for 3 months
Health Condition(s) Keyword		Amyotrophic lateral sclerosis, neurodegenerative disease
Intervention(s) Keyword
Health Condition(s) Code		G122 (ICD10)
Intervention(s) Code
Primary Outcome(s)		Safety
Secondary Outcome(s)		Nutritional status, height, weight, BMI, Mini Nutritional Assessment, Subjective Global Assessment, somatic fat volume The revised ALS functional rating scale Presence or absence of ALS-related events (gastrostomy, pneumonia, non-invasive positive pressure ventilation, ventilator placement, tracheostomy, death) Analysis by compliance rate of internal medication

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	Ajinomoto Co.
Secondary Sponsor	Not applicable

Source of Monetary Support	the Japan Society for the Promotion of Science KAKENHI (grant numbers 23K16642)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Hiroshima University Certified Review Board
Address	1-2-3 Kasumi, Minamki-ku, Hiroshima, Japan, Hiroshima, Hiroshima
Telephone	+81-82-257-1551
E-Mail	iryo-sinsa@office.hiroshima-u.ac.jp
Approval Status	Approval
Date of approval

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history