Amyotrophic Lateral Sclerosis
Conditions
Interventions
Group A : Early-stage Patients:Bushen Jianpi Granules + Myasthenia Plaster
Group B : Early-stage Patients:Bushen Jianpi Granules + Placebo Plaster
Group A: Advanced-stage Patients:Treatment Group: Wenshen Jianpi Granules + Myasthenia Plaster
Group B: Advanced-stage Patients:Wenshen Jianpi Granules + Placebo Plaster
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Consistent with the diagnostic criteria for amyotrophic lateral sclerosis (ALS): Definite ALS, Probable ALS, or Probable ALS – Laboratory-supported. 2: Each item of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) scores = 2 points, with the three items of dyspnea, orthopnea and respiratory insufficiency all scoring 4 points. 3: Forced Vital Capacity as percentage of predicted value (FVC%) = 70% 4: Disease duration of 3 years or less (calculated from the first onset of any ALS symptoms) 5: TCM syndrome differentiation: Spleen qi deficiency and Kidney yang deficiency 6: Aged 35 to 75 years inclusive, with no restriction on gender. 7: The patient or legal representative agrees to observation, treatment and follow-up, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Patients diagnosed with familial ALS 2: Subjects with other neurological disorders mimicking ALS symptoms or affecting drug efficacy evaluation, e.g., cervical spondylotic myelopathy, lumbar diseases, dementia. 3: Subjects with motor nerve conduction block or abnormal sensory nerve conduction detected by electromyography (EMG), or with substantial lesions on CT/MRI imaging that can account for the clinical manifestations. 4: Use of riluzole (Rilutek) or edaravone within 1 month before enrollment. 5: Patients who have undergone spinal surgery after the onset of ALS. 6: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal, or serum creatinine (Scr) exceeding the upper reference limit. 7: Patients with other severe primary diseases involving the nervous system, heart, lungs, hematopoietic system or endocrine system, as well as those with mental disorders. 8: Subjects with suspected or confirmed history of alcohol or drug abuse. 9: Pregnant or lactating women, as well as subjects of childbearing potential (including male subjects with heterosexual activity and their female partners of childbearing potential) who plan to become pregnant or refuse to use effective contraception from screening initiation through 3 months after drug discontinuation. 10: Subjects with known or suspected allergy to the investigational drug, rubber plaster or their excipients. 11: Subjects who have participated in other clinical trials within 3 months prior to screening. 12: Subjects deemed unsuitable for this clinical trial by the investigator, including those with poor compliance or high risk of trial withdrawal, such as patients who cannot take medication on schedule or those without dedicated caregivers to apply external preparations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ALSFRS-R and ALS-RRIT scores from baseline after 36 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ALSAQ-40 scores from baseline after treatment;Changes in ALSFRS-R and ALS-SSIT scores from baseline after treatment;Changes in FVC% from baseline after treatment;Incidence and time to occurrence of endpoint events (death; tracheotomy; persistent ventilator dependence) after treatment;Changes in total standard scores of Rasch Overall Disability Scale (ROADS) from baseline after treatment; | — |
Countries
China
Contacts
Public ContactXiangjun Chen
Huashan Hospital, Fudan University
Outcome results
None listed