Amyotrophic lateral sclerosis
Conditions
Interventions
Oryzanol group:Intramuscular injection of Oryzanol injection (40mg/day) for 20 days, followed by oral administration of Oryzanol tablets (600mg/day) for 60 days
Placebo group:Intramuscular injection of sterile injection water (2ml/day) for 20 days, followed by oral administration of starch tablets (600mg/day) for 60 days.
Sponsors
First Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with clinically confirmed or probable ALS who meet the diagnostic criteria of El Escorial and Awaji 2. Age> 18 years old 3. Disease severity (1) The ALSFRS-R score was > = 2 points, and the respiratory function score was 4 points (mild-moderate patients) (2) ALSFRS-R score decreased by 1-4 points within 3 months of the screening period (rapid disease progression) 4. Respiratory function: %FVC >= 80% (good respiratory function) 5. Compliance: understand and comply with the trial process, and voluntarily sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Cognitive impairment: the MMSE scale score is lower than the following thresholds (1) Illiterate group 3 times the upper limit of normal (2) Active hepatitis, liver cirrhosis, etc 5. Cardiovascular disease: the following conditions have occurred in the past 6 months (1) Acute myocardial infarction (2) Interventional therapy (3) Heart failure 6. Other serious diseases (1) Malignant tumors (2) Hematologic diseases (3) Digestive system diseases, etc 7. History of allergies: allergy to gamma oryzanol or its components 8. Pregnancy/lactation: Women of childbearing age need to have a negative pregnancy test 9. Recent clinical trials: participation in other drug trials within 30 days before screening 10. Investigator's judgment: other conditions that may interfere with the safety or results of the test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALSFRS-R Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Endpoint event;Gripping power;%FVC;ALSAQ-40 Score; | — |
Countries
China
Contacts
Public ContactHonglin Feng
First Affiliated Hospital of Harbin Medical University
Outcome results
None listed