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Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone

NCT07575516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

DRUG

Risperidone 4mg/day

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

DRUG

Ashwagandha

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Masnaeni Awaliah, MD · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Indonesia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07575516 on ClinicalTrials.gov