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Clinical Trial Summary

This is a Phase II, single centre, randomized, parallel, double blind, placebo-controlled clinical trial to determine the safety of Withania somnifera in participants with Amyotrophic Lateral Sclerosis (ALS).


Clinical Trial Description

There will be up to 75 participants randomized 1:1:1 to receive either high dosage Withania somnifera extract (1088 mg daily), medium dosage Withania somnifera extract (544 mg daily) or matching placebo. The study will consist of a Screening Period, Randomization visit, Baseline visit, and Follow-up visits. The treatment period will be 8 weeks and a final follow up call will occur at Week 9. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05031351
Study type Interventional
Source Sunnybrook Health Sciences Centre
Contact Jake Wimmer
Phone 416-480-6100
Email jake.wimmer@sri.utoronto.ca
Status Recruiting
Phase Phase 2
Start date October 19, 2021
Completion date September 2022

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