motor neuron disease
Conditions
Interventions
Experimental group:Dietary recommendations+ Wanshili Longbao silkworm pupa powder solid beverage (food production license number: XSY20240701) Main ingredients: fully active mulberry cocoon pupa powde
Control group:Dietary recommendations+ placebo, 5% of the effective ingredients of the investigational drug, unrecognizable in appearance, taken 3 times a day, 1 pack each time, half an hour before mo
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants must voluntarily agree to participate in the clinical research, fully understand the study, be informed about the details, and sign the Informed Consent Form (ICF). Participants should be willing and able to follow and complete all study procedures. 2. Gender is not restricted. Age at the time of signing the ICF: = 18 years and = 80 years. 3. Diagnosed with ALS according to the 2020 Gold Coast criteria for confirmed or suspected ALS. The duration of illness from onset to randomization must be = 4 years. Prior to enrollment, all ALSFRS-R scores must be = 2 points, and during the screening period (within 3 months), the ALSFRS-R must have decreased by 1 to 4 points (= 1 and = 4). 4. Nutritional risk score of = 3 points (based on the NRS2002 nutritional risk screening tool) at the time of screening. 5. General health status is acceptable, with an ECOG score of = 2 points. 6. Agree to provide peripheral blood, stool, and urine samples for biomarker analysis during the study.
Exclusion criteria
Exclusion criteria: 1. Patients with other neurological disorders that mimic ALS symptoms or may affect the evaluation of drug efficacy, such as cervical spondylotic myelopathy, lumbar spondylosis, or dementia. 2. Patients with autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, or vitiligo. 3. Patients with severe renal insufficiency (creatinine clearance rate 3 times the upper limit of normal) or other liver diseases such as acute or chronic active hepatitis, cirrhosis. Patients with acute myocardial infarction, those who have undergone interventional treatment within the past 6 months, heart failure classified as NYHA class III-IV, or those with severe primary diseases of the nervous, cardiovascular, pulmonary, hematopoietic, or endocrine systems, as well as psychiatric disorders. 4. Patients with suspected or known history of alcohol or drug abuse. 5. Expected survival period of = 3 months. 6. Pregnant or lactating women, or subjects of reproductive age (including male participants with heterosexual behavior and their female partners) who plan to become pregnant or are unwilling to use effective contraception from the start of screening until 3 months after discontinuing the study medication. 7. Individuals allergic to any of the ingredients in the investigational product. 8. Patients who have participated in other drug trials or are currently enrolled in clinical trials within 30 days prior to screening. 9. Patients with other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation, or those deemed unsuitable by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Sacopenia prevalence;Quality of life;Blood routine;blood biochemical;Urinalysis;Inflammatory indicators;electrocardiogram; | — |
Primary
| Measure | Time frame |
|---|---|
| Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R);Hemoglobin;albumin;serum prealbumin;serum transferrin;Diagnostic criteria of the 2019 Asian Sarcopenia Working Group;25-hydroxyvitamin d;D-Dimer;Global Disability Assessment Scale for Amyotrophic Lateral Sclerosis Syndrome (ROADS);Respiratory Function; | — |
Countries
China
Contacts
Public Contactyang gaoyi
Hangzhou First People's Hospital
Outcome results
None listed