Schizophrenia PatientsPhase 2WSE-SCZNCT07575516
Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone
A Phase 2 study testing Risperidone 4mg/day and Ashwagandha in people with Schizophrenia Patients and Neuroinflammation, run by Hasanuddin University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Schizophrenia Patients, Neuroinflammation
- What is being tested?
- Risperidone 4mg/day and Ashwagandha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2025to 31 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
South Sulawesi Mental Hospital (RSKD Dadi)
Makassar, South Sulawesi, 90245
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Schizophrenia Patients, Neuroinflammation
- Being tested
- Risperidone 4mg/day, Ashwagandha, Placebo
- Keywords
- Schizophrenia, Ashwagandha, Withania somnifera, PANSS, Inflammation, Interleukin-1beta
- Medical subject headings
- Neuroinflammatory Diseases, Schizophrenia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone 4mg/dayDrug
Risperidone is administered as standard antipsychotic therapy according to clinical practice guidelines for the treatment of schizophrenia.
AshwagandhaDrug
Also called Withania somnifera
Standardized extract of Ashwagandha (Withania somnifera) 1000mg/day administered as an adjunctive therapy in combination with risperidone during the study period
PlaceboOther
Placebo administered alongside risperidone, matched in appearance to the Ashwagandha preparation, used as a control condition.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Risperidone 4mg/day; Drug: Ashwagandha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to week 8
Secondary outcomes (3)
Change in Positive and Negative Syndrome Scale (PANSS) total score
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.
Measured: Baseline to week 8
Change in Positive and Negative Syndrome Scale subscale scores (positive, negative, general psychopathology)
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.
Measured: Baseline to week 8
Correlation between change in serum Interleukin-1beta levels and change in Positive and Negative Syndrome Scale (PANSS) total score
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.
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Oct 2025
- Primary completion30 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masnaeni Awaliah, Hasanuddin University
- Investigators
- Masnaeni Awaliah, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575516
- Sponsor's protocol ID
- UH25040276
- Acronym
- WSE-SCZ
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07575516
- Acronym / sponsor ID
- WSE-SCZ / UH25040276
- Conditions
- Schizophrenia Patients, Neuroinflammation
- Keywords
- Schizophrenia, Ashwagandha, Withania somnifera, PANSS, Inflammation, Interleukin-1beta
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Risperidone in combination with a placebo | Placebo comparator | Drug: Risperidone 4mg/day, Other: PlaceboParticipants receive standard antipsychotic therapy with risperidone 4mg/day in combination with a placebo as a control condition for 8 weeks |
| Risperidone in combination with Ashwagandha extract | Experimental | Drug: Risperidone 4mg/day, Drug: AshwagandhaParticipants receive antipsychotic therapy with risperidone 4mg/day in combination with Ashwagandha (Withania somnifera) extract 1000mg/day as an adjuvant therapy for 8 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone 4mg/dayRisperidone is administered as standard antipsychotic therapy according to clinical practice guidelines for the treatment of schizophrenia. | Drug | Risperidone in combination with Ashwagandha extract, Risperidone in combination with a placebo |
| AshwagandhaAlso: Withania somniferaStandardized extract of Ashwagandha (Withania somnifera) 1000mg/day administered as an adjunctive therapy in combination with risperidone during the study period | Drug | Risperidone in combination with Ashwagandha extract |
| PlaceboPlacebo administered alongside risperidone, matched in appearance to the Ashwagandha preparation, used as a control condition. | Other | Risperidone in combination with a placebo |
Primary outcome
Change in serum Interleukin-1beta levels
Time frame: 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
3 secondary outcomes
Change in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Baseline to week 8
Change in Positive and Negative Syndrome Scale subscale scores (positive, negative, general psychopathology)
Time frame: Baseline to week 8
Correlation between change in serum Interleukin-1beta levels and change in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Baseline to week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masnaeni Awaliah, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Risperidone 4mg/day and Ashwagandha in people with Schizophrenia Patients and Neuroinflammation, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum Interleukin-1beta levels (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.