This trial is evaluating whether Withania somnifera will improve 1 primary outcome, 5 secondary outcomes, and 2 other outcomes in patients with Lateral Sclerosis. Measurement will happen over the course of Baseline to 8 weeks.
This trial requires 75 total participants across 3 different treatment groups
This trial involves 3 different treatments. Withania Somnifera is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
"Despite a limited clinical experience with ALS, our study suggests that the clinical features of ALS are similar to those of Parkinson's and may even be characterized by a Parkinsonian phenotype. As the clinical features differ depending on whether patients present or develop the disease while still in their 40s versus the 60s, new classification systems may have to be devised." - Anonymous Online Contributor
"The main goal of research in this field is to develop therapies which will halt the course of the disease and hopefully cure it. The only therapies currently being used to stop the progression of the disease are medications which reduce the effects on nerves of the motor system. Studies using the mouse model show that it is possible to stop or slow down the breakdown of the motor neurons of the central nervous system. Although a cure for amyotrophic lateral sclerosis (ALS) is still elusive, these findings are a great improvement on the current situation and will lead to further research." - Anonymous Online Contributor
"The mechanism of causation of amyotrophic lateral sclerosis remains unknown. Autoimmunity probably plays a major role. The only conclusive evidence is that antibodies to the nicotinic receptor are found specifically in some patients with ALS. Whether viral agents, immune-complex deposition or a rare genetic condition causes amyotrophic lateral sclerosis remains unknown. But it is likely that a combination of factors causes the disorder." - Anonymous Online Contributor
"Most treatments are supportive, depending on the cause or causes of the disease, stage, age and lifestyle of the person. Many people experience significant improvement in quality of life and quality of life of people with ALS improves as their disease progresses and, ultimately, the person dies.\n" - Anonymous Online Contributor
"An estimated 100,000 diagnosed cases of amyotrophic lateral sclerosis (ALS) will be diagnosed by the year 2020 in the United States. By year 2017 an estimated 50,000 new cases will have happened per year. This has resulted in a decline of about 35% in the incidence of ALS in the United States in the 20th century." - Anonymous Online Contributor
"Decreased arm muscle volume, finger claw hands, bulbar symptoms, and spasticity and clonus are signs of ALS. The lack of limb muscle atrophy may be a clue to the possibility of an underlying neurological disorder in ALS." - Anonymous Online Contributor
"The ALS/mRS classification and a recent genetic association study have led to the identification of two genes, UBQLN1 (alias C9orf72) and SOD1 (alias ALS2) with a strong association with the disease. These genes could be candidate drug targets in SOD1 deficient mouse models. However, the most recent candidate gene, TDP-43, has not been identified within the confines of the most commonly used mouse models for SOD1." - Anonymous Online Contributor
"Data from a recent study suggest that the presence of autoimmune polyantibodies is unlikely to be the sole trigger for most forms of ALS and that the pathogenesis is likely multi-factorial. The role of viral infection and exposure to metals such as arsenic, lead and inhalants in ALS deserves further investigation." - Anonymous Online Contributor
"There was no significant difference among the mean values of the two groups at follow up period (mean = 4.5 and 4.5, respectively). Neither the overall improvement and relapse frequency at week 6 had a significant difference between the two groups. No side effect was reported in any of the groups. No toxicity was reported in any of the groups." - Anonymous Online Contributor
"Withania somnifera exerts its toxicity by a range of mechanisms. Withania somnifera at various doses in rats induced hepato- and kidney-damage of different severity, with the most severe damage being observed at the higher doses." - Anonymous Online Contributor
"WS treatment has beneficial health effects for those with ALS. There seem to be positive associations between withWS therapy and improvements in HRQoL. Whether this translates to meaningful improvements in quality of life for people with ALS remains to be determined." - Anonymous Online Contributor
"These data suggest that the life expectancy for persons with a diagnosis of ALS remains low. In addition, persons with the same diagnosis of ALS are not only at risk of dying young, they may be at increased risk of dying shortly after onset of symptoms, perhaps reflecting a more rapid rate of disease progression." - Anonymous Online Contributor