amyotrophic lateral sclerosis
Conditions
Interventions
Experimental group:Basic treatment + Qiangli Dingxuan tablets (200-300mL at a time 2 times a day)
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) in Western medicine and the diagnostic criteria for impotence in traditional Chinese medicine; (2)Age 18-75 years old (inclusive) gender is not limited; (3)The Modified Amyotrophic Lateral Sclerosis Scale score (ALSFRS-R) =scored 2 points for each item (4 points for dyspnea orthopnea and respiratory insufficiency); (4)Subjects voluntarily participate and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1)Those diagnosed with familial ALS or family members of familial ALS; (2)Patients receiving non-invasive ventilation tracheostomy and/or gastrostomy or with more severe disease with an expected survival of less than 1 year; (3)Those with other serious lung diseases severe heart liver kidney hematology tumors and other primary diseases or severe active mental illness or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 times the upper limit of normal and/or blood creatinine (Scr) = the upper limit of normal; (4)Pregnant or lactating women; (5)Those who are allergic to the experimental drug or the components of the experimental drug; (6)Those who have participated in other clinical trials in the past 3 months; (7)In the opinion of the investigator there is any other disease or condition that may limit or preclude participation in the study or affect the evaluation of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The value/rate of change from baseline in the ALSFRS-R score value;The value/rate of change from baseline in the ALSAQ-40 score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of disease progression;Changes in TCM pattern scores;Survival time;Muscle strength measurement;Composite endpoint event rate and time to occurrence;The value/rate of change from baseline in the ROADS score;Single symptom response rate;The value/rate of change from baseline in the FVC%; | — |
Countries
China
Contacts
Public ContactJinmin Liu
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed