This study intends to evaluate the efficacy and safety of Dong Lingsheng Ji Granule in the treatment of amyotrophic lateral sclerosis (spleen deficiency, kidney-yang deficiency syndrome) in comparison with riluzole, so as to provide data support for marketing application or subsequent clinical research design.
This study proposed the multicenter, randomized, double-blind, double simulation, positive drug parallel contrast the bad effect of experimental design, into the treatment group 72 cases, control group of 72 cases with the azole comparison, evaluation Dong Ling raw grain treatment on muscle atrophy amyotrophic lateral sclerosis (lack of temper, kidney Yang deficiency syndrome) efficacy and safety, for applications or follow-up clinical study design to provide data support.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally;
Huolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally.
Peking University Third Hospital
Beijin, China
RECRUITINGALSFRS-R scores
Changes in ALSFRS-R scores from baseline after 48 weeks of treatment, The ALSFRS-R scale (ALS Functional Rating Scale) includes 12 items including medulla oblongata function, limb function and respiratory function, with a total score of 48. The lower the score, the more serious the neurological function damage.
Time frame: 48 weeks
FVC%
Change in FVC% from baseline after 48 weeks of treatment
Time frame: 48 weeks
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