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

7 mei 2026 bijgewerkt door: Masnaeni Awaliah, Hasanuddin University

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 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

80

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Indonesië
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesië, 90245
        • South Sulawesi Mental Hospital (RSKD Dadi)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Risperidone in combination with a placebo
Participants receive standard antipsychotic therapy with risperidone 4mg/day in combination with a placebo as a control condition for 8 weeks
Geneesmiddel: Risperidone 4mg/day
Risperidone is administered as standard antipsychotic therapy according to clinical practice guidelines for the treatment of schizophrenia.
Ander: Placebo
Placebo administered alongside risperidone, matched in appearance to the Ashwagandha preparation, used as a control condition.
Experimenteel: Risperidone in combination with Ashwagandha extract
Participants receive antipsychotic therapy with risperidone 4mg/day in combination with Ashwagandha (Withania somnifera) extract 1000mg/day as an adjuvant therapy for 8 weeks
Geneesmiddel: Risperidone 4mg/day
Risperidone is administered as standard antipsychotic therapy according to clinical practice guidelines for the treatment of schizophrenia.
Geneesmiddel: Ashwagandha
Standardized extract of Ashwagandha (Withania somnifera) 1000mg/day administered as an adjunctive therapy in combination with risperidone during the study period
Andere namen:
  • Withania somnifera

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in serum Interleukin-1beta levels
Tijdsspanne: Baseline to week 8
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Positive and Negative Syndrome Scale (PANSS) total score
Tijdsspanne: Baseline to week 8
Change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to Week 8. The PANSS total score ranges from 30 to 210, with higher scores indicating more severe schizophrenia symptoms. A reduction in score indicates clinical improvement.
Baseline to week 8
Change in Positive and Negative Syndrome Scale subscale scores (positive, negative, general psychopathology)
Tijdsspanne: Baseline to week 8
Assessment of changes in Positive and Negative Syndrome Scale (PANSS) subscale scores from baseline to Week 8. The PANSS includes positive symptom, negative symptom, and general psychopathology subscales. Higher scores indicate more severe psychopathology, and reductions in scores indicate improvement.
Baseline to week 8
Correlation between change in serum Interleukin-1beta levels and change in Positive and Negative Syndrome Scale (PANSS) total score
Tijdsspanne: Baseline to week 8
Correlation between changes in serum Interleukin-1 beta levels and changes in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to Week 8 using correlation analysis (e.g., Pearson or Spearman correlation coefficient). The PANSS total score ranges from 30 to 210, with higher scores indicating more severe schizophrenia symptoms.
Baseline to week 8

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hasanuddin University

Onderzoekers

  • Hoofdonderzoeker: Masnaeni Awaliah, MD, Hasanuddin University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2025

Primaire voltooiing (Werkelijk)

30 januari 2026

Studie voltooiing (Werkelijk)

31 januari 2026

Studieregistratiedata

Eerst ingediend

2 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UH25040276

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data (IPD) will not be shared due to privacy and confidentiality concerns, as well as institutional and ethical restrictions on data sharing. Only aggregated data will be reported in publications.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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