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

NCT07541157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Schizophrenia Patients

Interventions

DRUG

Risperidone 4mg/day

Participants receive risperidone in standard therapeutic doses as antipsychotic treatment for schizophrenia during the study period.

DIETARY_SUPPLEMENT

Ashwagandha

Ashwagandha extract (Withania somnifera) administered as adjunctive therapy in combination with risperidone 4mg/day for 8 weeks.

OTHER

Placebo

Placebo administered in combination with risperidone for 8 weeks in the control group, matched in appearance to Ashwagandha to maintain blinding.

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Rina Nurul Qalbi, MD · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541157 on ClinicalTrials.gov