drugset / Trial / NCT07575516

Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone

NCT07575516

Phase 2 Completed 80 enrolled Hasanuddin University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-10-01
Primary completion
2026-01-30
Completion
2026-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ashwagandha Traditional medicine (herbal / TCM) 1000 mg
Background Risperidone Other / unclassified 4 mg

Indications