Amyotrophic lateral sclerosis
Conditions
Interventions
High-dose group:Shenrong granules, 2 bags/time, 3 times/day
Low-dose group:Shenrong granules, 2 bags/time, 3 times/day
Placebo control group:Shenrong granules placebo, 2 bags/time, 3 times/day
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the western medical diagnostic criteria for amyotrophic lateral sclerosis (ALS) (clinically confirmed ALS, clinically likely ALS, clinically likely ALS - laboratory support); (2) In line with the traditional Chinese medicine flaccence disease du yuan deficiency syndrome differentiation standards; (3) Age 45-70 years old (including both ends), gender is not limited; (4) The score of modified amyotrophic Lateral sclerosis Function Scale (ALSFRS-R) was =2 points for each item (dyspnea, upright respiration and respiratory insufficiency were all 4 points); (5) The percentage of forced vital capacity to the estimated value (FVC%) =70%, and non-invasive ventilator was not used; (6) The course of the disease is within 2 years (from the first appearance of any symptoms of ALS); (7) Patients received or did not receive standard treatment medications (Edaravone and/or Riluzole) before enrollment and remained on standard treatment throughout the study period; (8) The subject voluntarily signs a written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with progressive bulbar paralysis and primary lateral sclerosis; Or with other neurological diseases similar to ALS that affect the evaluation of drug efficacy, such as cervical spondylotic myelopathy, syringomyelia, spinal cord and brain stem tumors, Hirayama disease, multifocal motor neuropathy, multiple sclerosis, Guillain Barre syndrome, Parkinson's disease, and dementia; (2) Those who had undergone gastrostomy at the time of enrollment, or had dysphagia and could not guarantee normal diet and drug intake; (3) Patients with severe disease whose expected survival time is less than 1 year (for example, patients who use non-invasive ventilation for more than 10 hours per day, maintain pulse oxygen less than 95%, or cannot tolerate nasal feeding enteral nutrition support), and it is difficult to make an accurate assessment of the effectiveness and safety of the investigational drug; (4) Patients who had a history of spinal surgery in the first half year before screening; (5) Patients with other serious lung diseases, or the required treatment may affect the assessment of respiratory function; (6) Accompanied by serious heart, liver, kidney, blood, tumor and other primary diseases, or severe active mental illness; (7) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 1.5 times the upper limit of normal value, and (or) serum creatinine (Scr) = the upper limit of normal value; (8) Pregnant or lactating women, and those who have a family plan or do not want to take effective contraceptive measures within 6 months after enrollment to the end of the trial; (9) Suspected or have a history of alcohol or drug abuse; (10) Allergic to the investigational drug product or its ingredients; (11) Participants in other clinical trials within the last 3 months; (12) The presence, in the opinion of the investigator, of any other disease or condition that may limit or prevent participation in the study or affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical value of Change of ALSFRS-R score from baseline after treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of change of ALSFRS-R score from baseline after treatment;Numerical value/rate of change of ROADS score from baseline after treatment;Numerical value/rate of change of FVC% from baseline after treatment;Numerical value/rate of change of ALSAQ40 score from baseline after treatment;Numerical value/rate of change of TCM syndrome score from baseline after treatment;Numerical value/rate of change of NfL from baseline after treatment;Composite end point events (continuous ventilator dependence: =22 hours per day for =10 consecutive days; Tracheotomy; Death) incidence and time of occurrence, whichever comes first; | — |
Countries
China
Contacts
Public ContactDongsheng Fan
Peking University Third Hospital
Outcome results
None listed