Amyotrophic lateral sclerosis
Conditions
Interventions
Experimental group:Huoling Shengji granules, 1 bag each time, Bid, oral
Control group:Huoling Shengji granules placebo, 1 bag each time, Bid, oral
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 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)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); (3) The percentage of forced vital capacity to the estimated value (FVC%) =70%; (4) The course of the disease is within 3 years (from the first appearance of any symptoms of ALS); (5) Disease progression rate ?FS=(48-ALSFRS-R total score at screening)/diseaseduration(months) > 0.3 points/month; (6) Stable use of riluzole and/or edaravone within 30 days prior to enrollment; (7) TCM syndrome differentiation of spleen qi deficiency and kidney yang deficiency; (8) Age 18 to 65 years (inclusive of 18 and 65 years), gender not restricted; (9) Willing to participate in this clinical trial, informed consent and written informed consent form signed.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of familial or hereditary ALS; (2) Underwent gastrostomy, or has dysphagia that cannot ensure adequate intake of food and medication; (3) Has other neurological diseases that are similar to ALS symptoms or may affect the evaluation of drug efficacy, such as cervical spondylotic myelopathy, lumbar disease, dementia, myasthenia gravis, Parkinson's disease, syringomyelia, spinal and brainstem tumors, Hirayama disease, multifocal motor neuropathy, multiple sclerosis, Guillain-Barré syndrome, etc.; (4) Has other severe pulmonary diseases (such as acute exacerbation of COPD), or the required treatment may affect the assessment of respiratory function; (5) Has a history of spinal surgery within six months prior to enrollment; (6) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of the normal reference range, or serum creatinine (Scr) > upper limit of the normal reference range (if the investigator determines that the transient elevation of transaminases is due to diet, etc., one retest is allowed during the screening period); (7) Has diabetes with poor blood sugar control (glycated hemoglobin (HbA1c) = 8%); (8) Has other severe primary diseases of the nervous system, heart, digestive system, hematopoietic system, or endocrine system, or has a psychiatric disorder; (9) Has a history of suspected or confirmed alcohol or drug abuse; (10) Pregnant or breastfeeding women, subjects of childbearing age (including male subjects with heterosexual behavior and their female partners with reproductive potential) who plan to conceive or are unwilling to take effective contraceptive measures from the start of screening to 3 months after discontinuation of the study drug; (11) Known or suspected allergy to the investigational drug or its components; (12) Participated in another interventional clinical trial and received investigational intervention within three months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in ALSFRS-R score from baseline ; | — |
Secondary
| Measure | Time frame |
|---|---|
| End point events (Death;Tracheotomy; continuous ventilator dependence) incidence and time of occurrence;Combined Assessment of Function and Survival;The change in ALSFRS-R score from baseline;The change from baseline in the total score of the ROADS criteria ;Numerical value/rate of change of NfL from baseline ;The change from baseline in FVC% ;The change from baseline in the total score of TCM syndromes, the total score of main symptoms, the total score of secondary symptoms, and the score of each individual symptom ; | — |
Countries
China
Contacts
Public ContactDongsheng Fan
Peking University Third Hospital
Outcome results
None listed