Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone

NCT07575516 | Completed Phase 2

• 1 other identifier: UH25040276
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia Patients; Neuroinflammation

Keywords

Schizophrenia; Ashwagandha; Withania somnifera; PANSS; Inflammation; Interleukin-1beta

Outcome Measures

Primary Outcomes (1)

• Change in serum Interleukin-1beta levels

  The primary outcome is the change in serum Interleukin-1beta levels measured to evaluate the anti-inflammatory effect of the intervention

  Baseline to week 8

Secondary Outcomes (3)

• Change in Positive and Negative Syndrome Scale (PANSS) total score

  Baseline to week 8

• Change in Positive and Negative Syndrome Scale subscale scores (positive, negative, general psychopathology)

  Baseline to week 8

• Correlation between change in serum Interleukin-1beta levels and change in Positive and Negative Syndrome Scale (PANSS) total score

  Baseline to week 8

Study Arms (2)

Risperidone in combination with a placebo

PLACEBO COMPARATOR

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

Drug: Risperidone 4mg/day; Other: Placebo

Risperidone in combination with Ashwagandha extract

EXPERIMENTAL

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

Drug: Risperidone 4mg/day; Drug: Ashwagandha

Interventions

Risperidone 4mg/day DRUG

Risperidone is administered as standard antipsychotic therapy according to clinical practice guidelines for the treatment of schizophrenia.

Risperidone in combination with Ashwagandha extract; Risperidone in combination with a placebo

Ashwagandha DRUG

Standardized extract of Ashwagandha (Withania somnifera) 1000mg/day administered as an adjunctive therapy in combination with risperidone during the study period

Also known as: Withania somnifera

Risperidone in combination with Ashwagandha extract

Placebo OTHER

Placebo administered alongside risperidone, matched in appearance to the Ashwagandha preparation, used as a control condition.

Risperidone in combination with a placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

South Sulawesi Mental Hospital (RSKD Dadi)

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Neuroinflammatory Diseases; Schizophrenia; Inflammation

Interventions

Risperidone; Ashwagandha

Condition Hierarchy (Ancestors)

Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Masnaeni Awaliah, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are randomly assigned to either the control group receiving risperidone alone or the intervention group receiving risperidone in combination with Ashwagandha extract.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are assigned to one of two parallel groups: a control group receiving standard therapy with risperidone and an intervention group receiving risperidone in combination with Ashwagandha extract. Outcomes are compared between groups after the intervention period

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 8, 2026
• Study Start: October 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)