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COMPLETED
NCT07541157
NA

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

Sponsor: Hasanuddin University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

MALE

Age Range

20 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-09-01

Completion Date

2026-01-31

Last Updated

2026-04-23

Healthy Volunteers

No

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.

Locations (1)

Dadi Psychiatric Hospital (RSJ Dadi) Makassar

Makassar, South Sulawesi, Indonesia