drugset
drugset / Trial / NCT03437668

Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia

NCT03437668 ↗

Phase 2/3 Terminated 47 enrolled Chengappa, K.N. Roy, MD Stanley Medical Research Institute · collabUniversity of Maryland · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).

Timeline

Start
2018-12-01
Primary completion
2023-06-12
Completion
2023-06-12

Outcome

Missed primary endpoint

Stopped (Enrollment): “Unable to reach enrollment target due to COVID”

registry analysis (superiority test); Withania Somnifera Extract (WSE) vs Placebo Tablets; p = .31; Slope -0.22; Mixed Models Analysis NCT03437668 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject WSE Unknown 500 mg —

Indications

schizophrenia