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. 2023 May 9:15:1153973.
doi: 10.3389/fnagi.2023.1153973. eCollection 2023.

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

Xiaolu Liu  1   2   3 , Tingting Qin  4 , Tao Li  5 , Lei Shan  6 , Xiang Lei  7 , Xin Xu  8 , Bin Wen  8 , Yi Feng  9 , Ping Yin  4 , Dongsheng Fan  1   2   3
Affiliations

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

Xiaolu Liu et al. Front Aging Neurosci. .

Abstract

Background: There 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 analysis: In 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.

Discussion: Here, 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.

Keywords: Huoling Shengji granule; amyotrophic lateral sclerosis; flaccidity syndrome; randomized controlled trial; traditional Chinese medicine.

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Conflict of interest statement

LS was employed by Foshan Kaichuan Pharmaceuticals Co., Ltd. XLei was employed by Beijing Qi-Huang Technology Co., Ltd. XX and BW were employed by Shanghai Pharma Rare Disease Medicine Co., Ltd. The funder had the following involvement with the study, draft preparation and funding acquisition. Beijing Qi-Huang Technology Co., Ltd. is the contract research organization in the current trial. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Study workflow.
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