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概览

疾病领域	数量

内分泌与代谢疾病	1
神经系统疾病	1

排名前五的药物类型	数量

中药	1

关联

1

项与佛山市凯川医药科技有限公司相关的药物

Huolingshengji (Granules)

藿苓生肌

靶点-

作用机制-

在研机构

佛山市凯川医药科技有限公司 [+1]

原研机构

上海中医药大学

在研适应症

肌萎缩侧索硬化

非在研适应症-

最高研发阶段临床2/3期

首次获批国家/地区-

首次获批日期-

100 项与佛山市凯川医药科技有限公司相关的临床结果

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0 项与佛山市凯川医药科技有限公司相关的专利（医药）

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1

项与佛山市凯川医药科技有限公司相关的文献（医药）

2023-01-01·Frontiers in aging neuroscience

"Huoling Shengji granule" for amyotrophic lateral sclerosis: protocol for a multicenter, randomized, double-blind, riluzole parallel controlled clinical trial.

Article

作者: Fan, Dongsheng ; Qin, Tingting ; Shan, Lei ; Feng, Yi ; Lei, Xiang ; Wen, Bin ; Liu, Xiaolu ; Li, Tao ; Yin, Ping ; Xu, Xin

BackgroundThere is still a large demand for effective treatments to delay disease deterioration in amyotrophic lateral sclerosis (ALS). Typical symptoms of ALS are considered "flaccidity syndrome" in traditional Chinese medicine (TCM). Huoling Shengji Granule (HLSJ) is a TCM formula used to treat flaccidity syndrome. Results of preclinical tests and a previous clinical study support HLSJ as a novel drug for ALS patients. This trial proposed to examine whether a 48-week course of HLSJ is effective and safe for ALS patients diagnosed with the Chinese medicine syndrome of spleen qi insufficiency and kidney yang deficiency.Methods and analysisIn this phase II, multicenter, randomized, double-blind, riluzole parallel-controlled, superiority-design study, eligible participants had the equal opportunity to be assigned to receive either HLSJ or riluzole randomly. Eleven specialized ALS centers in Mainland China will recruit 144 patients for this trial. The primary and secondary outcomes included the change in the ALSFRS-R score and the Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) from baseline to Week 48.DiscussionHere, we endeavored to evaluate TCM for ALS using a standard evidence-based approach for the first time. In addition, the ROADS, a self-report linear-weighted questionnaire, was selected as a secondary outcome measure. We expect to offer a new reference for the outcome evaluation of ALS trials.Clinical trial registration:http://www.Chictr.org.cn, identifier ChiCTR2100044085.

100 项与佛山市凯川医药科技有限公司相关的药物交易

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100 项与佛山市凯川医药科技有限公司相关的转化医学

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