NCT04950933

The Treatment of Amyotrophic Lateral Sclerosis With Huollingshengji Granules

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)

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Huolingshengji Granules	1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally;
DRUG	Riluzole tablet	Huolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2021-07-06
• Last updated: 2021-07-08

Locations

1 site across 1 country: China