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

NCT07541157 | Completed

• 1 other identifier: UH25070479
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ashwagandha; BDNF; Cognitive function; Adjunctive therapy; Risperidone

Outcome Measures

Primary Outcomes (2)

• Change in serum BDNF levels

  Serum brain-derived neurotrophic factor (BDNF) levels measured using laboratory analysis.

  Baseline to Week 8

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

  Cognitive function assessed using the Montreal Cognitive Assessment Indonesian Version (MoCA-Ina). Scores range from 0 to 30, with higher scores indicating better cognitive function.

  Baseline to Week 8

Secondary Outcomes (1)

• Correlation between changes in cognitive function scores and serum BDNF levels

  Week 8

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive risperidone combined with Ashwagandha extract for 8 weeks.

Drug: Risperidone 4mg/day; Dietary Supplement: Ashwagandha

Control Group

PLACEBO COMPARATOR

Participants receive risperidone combined with a placebo for 8 weeks.

Drug: Risperidone 4mg/day; Other: Placebo

Interventions

Risperidone 4mg/day DRUG

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

Control Group; Intervention Group

Ashwagandha DIETARY_SUPPLEMENT

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

Intervention Group

Placebo OTHER

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

Control Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Only male participants are eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dadi Psychiatric Hospital (RSJ Dadi) Makassar

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Interventions

Risperidone; Ashwagandha

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rina Nurul Qalbi, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study used a double-blind design in which participants and outcome assessors were blinded to group allocation. Investigators were also blinded to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants are assigned to two parallel groups: a control group receiving risperidone monotherapy and an intervention group receiving risperidone combined with Ashwagandha. Outcomes are assessed at baseline and after 8 weeks of treatment.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: September 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)