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A Multi-center, Randomized, Double-blind, Positives Parallel Controlled, Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of Huollingshengji Granules in the Treatment of Amyotrophic Lateral Sclerosis (Spleen qi Deficiency, Kidney Yang Deficiency Syndrome)
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.
Age
45 - 70 years
Sex
ALL
Healthy Volunteers
No
Peking University Third Hospital
Beijin, China
Start Date
June 1, 2020
Primary Completion Date
December 31, 2021
Completion Date
December 31, 2022
Last Updated
July 8, 2021
144
ESTIMATED participants
Huolingshengji Granules
DRUG
Riluzole tablet
DRUG
Lead Sponsor
Peking University Third Hospital
Collaborators
NCT07322003
NCT05104710
NCT04715399
Data Source & Attribution
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