In the search for treatments to slow down amyotrophic lateral sclerosis (ALS), a traditional Chinese medicine formula called Huoling Shengji Granule (HLSJ) is being investigated. ALS, also known as Lou Gehrig’s disease, causes muscle weakness and is seen as a ‘flaccidity syndrome’ in traditional Chinese medicine. This multicenter clinical trial aims to evaluate the safety and efficacy of HLSJ in ALS patients with specific TCM imbalances. By comparing the ALS Functional Rating Scale-Revised (ALSFRS-R) score and the Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) over a 48-week period, researchers hope to provide a new reference for assessing outcomes in ALS trials. This study represents the first evidence-based approach to evaluating traditional Chinese medicine for ALS. To learn more about this groundbreaking research, explore the full article.
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.
Dr. David Lowemann, M.Sc, Ph.D., is a co-founder of the Institute for the Future of Human Potential, where he leads the charge in pioneering Self-Enhancement Science for the Success of Society. With a keen interest in exploring the untapped potential of the human mind, Dr. Lowemann has dedicated his career to pushing the boundaries of human capabilities and understanding.
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