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Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone
Sponsor: Hasanuddin University
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.
Official title: The Effectiveness of Ashwagandha Extract as an Adjuvant Therapy in Reducing Interleukin-1β Levels and Positive and Negative Syndrome Scale (PANSS) Scores in Schizophrenia Patients Receiving Risperidone
Key Details
Gender
MALE
Age Range
20 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-10-01
Completion Date
2026-01-31
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Risperidone 4mg/day
Risperidone is administered as standard antipsychotic therapy according to clinical practice guidelines for the treatment of schizophrenia.
Ashwagandha
Standardized extract of Ashwagandha (Withania somnifera) 1000mg/day administered as an adjunctive therapy in combination with risperidone during the study period
Placebo
Placebo administered alongside risperidone, matched in appearance to the Ashwagandha preparation, used as a control condition.
Locations (1)
South Sulawesi Mental Hospital (RSKD Dadi)
Makassar, South Sulawesi, Indonesia