Study on the safety and nutritional status improvement of L-arginine hydrochloride intervention for ALS

A before-after study on the safety and nutritional status improvement after L-arginine hydrochloride intervention in patients with amyotrophic lateral sclerosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061230001

Enrollment

Registered

2023-04-11

Start date

2023-05-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis Amyotrophic lateral sclerosis, neurodegenerative disease

Interventions

Taking L-arginine hydrochloride for 3 months

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
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	—

Contacts

Public ContactNaito Hiroyuki

Hiroshima Univetrsity Hospital

hi-naito@outlook.jp+81-82-257-5201

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026