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

This randomized controlled trial was conducted at South Sulawesi Mental Hospital (RSKD Dadi), South Sulawesi Province, Makassar, Indonesia.

Schizophrenia is a chronic and severe psychiatric disorder characterized by disturbances in perception, cognition, emotion, and behavior. In addition to neurotransmitter imbalances, increasing evidence suggests that neuroinflammation and immune dysregulation play important roles in the pathophysiology of schizophrenia. Elevated levels of pro-inflammatory cytokines, including interleukin-1 beta (IL-1β), have been associated with disease severity and symptom progression.

Risperidone, an atypical antipsychotic, is commonly used as a first-line treatment for schizophrenia and is effective in reducing positive symptoms. However, many patients continue to experience residual symptoms, particularly negative and cognitive symptoms. Therefore, adjunctive therapies targeting alternative pathways, such as inflammation, are being explored to improve treatment outcomes.

Ashwagandha (Withania somnifera) is a traditional medicinal plant with known anti-inflammatory, antioxidant, and neuroprotective properties. Preclinical and clinical studies suggest that Ashwagandha may modulate immune responses, reduce pro-inflammatory cytokines, and improve cognitive and behavioral functions. These properties make it a potential candidate as an adjunctive therapy in schizophrenia.

This study is designed to evaluate the effectiveness of Ashwagandha extract as an adjuvant to risperidone therapy in patients with schizophrenia. Participants diagnosed with schizophrenia are allocated to receive either standard treatment with risperidone alone or risperidone in combination with Ashwagandha extract. The primary outcomes of the study include changes in serum IL-1β levels and clinical symptom severity measured using the Positive and Negative Syndrome Scale (PANSS).