NCT07575516CompletedPhase 2
Effectiveness of Ashwagandha in Schizophrenia Patients on Risperidone
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 2 May 2026
- Start date
- 1 Oct 2025
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- Hasanuddin University
- Diseases
- Schizophrenia
- NCT number
- NCT07575516
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 1 Oct 2025 to the primary completion date, 30 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of anti-inflammatory drugs, antibiotics, or antioxidant agents
Other illness
- Presence of organic comorbid diseases
- History of substance abuse (NAPZA) within the last 1 year, except caffeine and nicotine
Other
- Intellectual disability (mental retardation)
Who the study is looking for
- 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
Age in the registry: 20 years to 45 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Sulawesi Mental Hospital (RSKD Dadi) Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.