Amyotrophic lateral sclerosis
Conditions
Interventions
Treatment group:Each subject was required to take Yi Kidney Tongluo Fu Yuan Tang for treatment twice a day as requested by the investigator. Standardized soup or formulated granules for 6 months of co
Sponsors
Institute Of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for Amyotrophic Lateral Sclerosis (ALS) in Western medicine and the diagnostic criteria for Weibing ( a TCM condition characterized by muscle weakness and atrophy) in Traditional Chinese Medicine; (2) Age between 18 and 75 years (inclusive), regardless of gender; (3) Each item score on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) is =2 points (with scores of 4 points for the three items: dyspnea, orthopnea, and respiratory insufficiency); (4) The subject voluntarily participates and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals diagnosed with familial amyotrophic lateral sclerosis (familial ALS) or family members of individuals with familial ALS; (2) Patients who have received non-invasive ventilation, tracheostomy and/or gastrostomy, or those with severe illness and an expected survival period of less than 1 year; (3) Individuals with other severe pulmonary diseases, severe cardiac, hepatic, renal, hematological, or neoplastic primary diseases, or severe active psychiatric disorders; those with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) = 3 times the upper limit of normal, and/or serum creatinine (Scr) = the upper limit of normal; (4) Pregnant or lactating women; (5) Individuals allergic to the investigational medicinal product or its components; (6) Individuals who have participated in another clinical trial within the past 3 months; (7) Any other disease or condition that the investigator deems may limit or hinder participation in the study or affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in ALSFRS-R score value after 6 months of medication compared to the baseline;Change in ALSAQ-40 scores from baseline in ALS patients who have been on medication for 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease progression rate;Monosymptomatic Treatment Response Rate;Muscle Strength Assessment;Change in Rasch Overall Assessment of the Damages Scale (ROADS) score from baseline / Change rate of Rasch Overall Assessment of the Damages Scale (ROADS) score from baseline;Traditional Chinese Medicine Symptom Efficacy Scoring;Survival period;Incidence and time of occurrence of composite endpoint events (persistent ventilator dependence: =22 hours per day for =10 consecutive days; tracheostomy; death), with the first occurring event taking precedence; | — |
Countries
China
Contacts
Public ContactWangzhong
Institute Of Basic Research In Clinical Medicine, China Academy of Chinese Medical Sciences
Outcome results
None listed