Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone (WSE-SCZ)

Hasanuddin University

Status and phase: Completed; Phase 2

Conditions: Neuroinflammation; Schizophrenia Patients

Treatments: Other: Placebo; Drug: Risperidone 4mg/day; Drug: Ashwagandha

Study type: Interventional

Funder types: Other

Identifiers

NCT07575516

UH25040276

Details and patient eligibility

About

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.

Full description

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).

Data are collected at baseline and after the intervention period. Statistical analysis is conducted to compare changes in IL-1β levels and Positive and Negative Syndrome Scale (PANSS) scores between groups. The study aims to determine whether the addition of Ashwagandha extract provides additional benefits in reducing inflammation and improving clinical outcomes compared to standard therapy alone.

The results of this study are expected to contribute to the understanding of the role of immunomodulatory interventions in schizophrenia and to support the development of complementary therapeutic strategies for improving patient outcomes.

Enrollment: 80 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients diagnosed with schizophrenia based on ICD-10/PPDGJ III criteria
• Aged 20-45 years
• Duration of illness ≤ 5 years
• Patients who have passed the acute phase (Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) < 15)
• Receiving risperidone 4 mg/day
• Willing to participate and provide written informed consent

Exclusion criteria

• Presence of organic comorbid diseases
• History of substance abuse (NAPZA) within the last 1 year, except caffeine and nicotine
• Use of anti-inflammatory drugs, antibiotics, or antioxidant agents
• Intellectual disability (mental retardation)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Risperidone in combination with a placebo

Placebo Comparator group

Description:

Participants receive standard antipsychotic therapy with risperidone 4mg/day in combination with a placebo as a control condition for 8 weeks

Treatment:

Drug: Risperidone 4mg/day

Other: Placebo

Risperidone in combination with Ashwagandha extract

Experimental group

Description:

Participants receive antipsychotic therapy with risperidone 4mg/day in combination with Ashwagandha (Withania somnifera) extract 1000mg/day as an adjuvant therapy for 8 weeks

Treatment:

Drug: Ashwagandha

Drug: Risperidone 4mg/day