NCT01793935

Sensoril® (Ashwagandha), an Immunomodulator and Anti-inflammatory Agent for Schizophrenia: A Parallel Group, Randomized Double Blind, and Placebo Controlled Study

Completed NA Results posted Last updated 8 December 2017

What this trial tests

NA trial testing Sensoril® in Schizophrenia in 68 participants. Completed in 7 July 2016.

Timeline

1 April 2013

Primary endpoint
7 July 2016

7 July 2016

Quick facts

Lead sponsor	K.N. Roy Chengappa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	68
Start date	1 April 2013
Primary completion	7 July 2016
Estimated completion	7 July 2016
Sites	1 location across United States

Drugs / interventions tested

• Sensoril®
• Placebo

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →

Sponsor

K.N. Roy Chengappa

Who can join

Adults 18 to 75, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Positive and Negative Syndrome Scale (PANSS)
  Time frame: Baseline and 12 Weeks
  The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms. PANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome. PANSS Negative subscale consists of 7 Items - (m

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NF-κB and STAT3 in glioblastoma: therapeutic targets coming of age.
   Gray GK, McFarland BC, Nozell SE, Benveniste EN. · · 2014 · cited 87× · PMID 25262780 · DOI 10.1586/14737175.2014.964211
2. Proinflammatory Cytokines IL-6 and TNF-<i>α</i> Increased Telomerase Activity through NF-<i>κ</i>B/STAT1/STAT3 Activation, and Withaferin A Inhibited the Signaling in Colorectal Cancer Cells.
   Chung SS, Wu Y, Okobi Q, Adekoya D, et al · · 2017 · cited 80× · PMID 28676732 · DOI 10.1155/2017/5958429
3. Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study.
   Chengappa KNR, Brar JS, Gannon JM, Schlicht PJ. · · 2018 · cited 46× · PMID 29995356 · DOI 10.4088/jcp.17m11826
4. Withaferin A inhibits lysosomal activity to block autophagic flux and induces apoptosis via energetic impairment in breast cancer cells.
   Muniraj N, Siddharth S, Nagalingam A, Walker A, et al · · 2019 · cited 32× · PMID 30698683 · DOI 10.1093/carcin/bgz015
5. Bioactive Compounds: Multi-Targeting Silver Bullets for Preventing and Treating Breast Cancer.
   Muniraj N, Siddharth S, Sharma D. · · 2019 · cited 31× · PMID 31618928 · DOI 10.3390/cancers11101563
6. <i>Withania somnifera</i>: Progress towards a Pharmaceutical Agent for Immunomodulation and Cancer Therapeutics.
   Kashyap VK, Peasah-Darkwah G, Dhasmana A, Jaggi M, et al · · 2022 · cited 29× · PMID 35335986 · DOI 10.3390/pharmaceutics14030611
7. Concomitant Inhibition of Cytoprotective Autophagy Augments the Efficacy of Withaferin A in Hepatocellular Carcinoma.
   Siddharth S, Muniraj N, Saxena NK, Sharma D. · · 2019 · cited 23× · PMID 30934990 · DOI 10.3390/cancers11040453
8. Withaferin A in the Treatment of Liver Diseases: Progress and Pharmacokinetic Insights.
   Xia Y, Yan M, Wang P, Hamada K, et al · · 2022 · cited 19× · PMID 34903587 · DOI 10.1124/dmd.121.000455