Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia
Status:
Completed
Trial end date:
2016-07-07
Target enrollment:
Participant gender:
Summary
Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or
to build resistance to stress or diseases in indigenous medical systems in India for
centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides,
withanosides, indosides, withaferin-A, others) with significant immunomodulatory,
anti-inflammatory and stress reducing properties.
This study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®)
will improve total, positive, negative symptoms, and stress in patients with schizophrenia.
The study will examine whether WSE reduces PANSS positive and negative symptoms and stress
scores in subjects, and whether these improvements are mediated by changes in inflammatory
immune indices. An additional aim will determine if patients receiving WSE will have fewer
adjustments to their psychotropic medications that those assigned to placebo. The study will
examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a
reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2
ratios normalize will likely have a greater magnitude of clinical improvement versus those
subjects whose immune ratios remain unbalanced.
The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic
medications in approximately 60 or more patients with schizophrenia with an exacerbation of
symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used
quite readily across low, middle and high income countries.