Clinical Trial

Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone

Study acronym: WSE-SCZ
Completed Phase 2
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Summary
This study aims to evaluate the effectiveness of Ashwagandha (Withania somnifera) extract as an adjuvant therapy in patients with schizophrenia who are receiving risperidone. Schizophrenia is a chronic mental disorder associated with neuroinflammation and immune dysregulation, including increased levels of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β). In this study, patients diagnosed with schizophrenia are given standard treatment with risperidone, with or without additional Ashwagandha extract. The primary outcomes are changes in Interleukin-1β levels and clinical symptoms assessed using the Positive and Negative Syndrome Scale (PANSS). The study aims to determine whether Ashwagandha extract supplementation can reduce inflammation and improve clinical symptoms in patients with schizophrenia. The findings support the use of Ashwagandha extract as a complementary therapy to enhance treatment outcomes in schizophrenia.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-02.
Trial Details
NCT Number NCT07575516
Lead Sponsor Hasanuddin University
Conditions Schizophrenia Patients, Neuroinflammation
Enrollment 80 participants
Start Date 2025-10-01
Primary Completion 2026-01-30 (estimated)
Study Completion 2026-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-12