CompletedNot Applicable

Effect of Ashwagandha as Adjunct Therapy on BDNF and Cognitive Function in Schizophrenia Patients

Indonesia80 participantsStarted 2025-09-01

Plain-language summary

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.

Who can participate

Age range

20 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in serum BDNF levels

Timeframe: Baseline to Week 8

Change in cognitive function (Montreal Cognitive Assessment Indonesian Version [MoCA-Ina] score)

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT07541157

SponsorHasanuddin University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Schizophrenia Patients trials