NCT07541157Completed
Effect of Ashwagandha as Adjunct Therapy on BDNF and Cognitive Function in Schizophrenia Patients
The Effect of Ashwagandha Therapy as an Adjunct on Serum BDNF Levels and Cognitive Function in Schizophrenia Patients Receiving Risperidone: A Double-Blind Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
This study aims to evaluate the effectiveness of Ashwagandha (Withania somnifera) as an adjunctive therapy in improving serum brain-derived neurotrophic factor (BDNF) levels and cognitive function in patients with schizophrenia receiving risperidone treatment. This study uses a controlled clinical trial design involving two groups: a control group receiving risperidone only and an intervention group receiving risperidone combined with Ashwagandha extract. Cognitive function is assessed using the Montreal Cognitive Assessment Indonesian version (MoCA-Ina), and serum BDNF levels are measured at baseline and after 8 weeks of treatment. The study also aims to compare changes in cognitive function and BDNF levels between the two groups and to analyze the correlation between cognitive improvement and changes in BDNF levels. The findings are expected to provide evidence regarding the potential role of Ashwagandha as an adjunctive therapy for cognitive impairment in schizophrenia.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 14 Apr 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Hasanuddin University
- Diseases
- Schizophrenia
- NCT number
- NCT07541157
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 1 Sept 2025 to the primary completion date, 31 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 (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 |
|---|---|---|---|
| Dadi Psychiatric Hospital (RSJ Dadi) Makassar Coordinator of this site? Confirm its status | Makassar | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.