Effect of Ashwagandha as Adjunct Therapy on BDNF and Cognitive Function in Schizophrenia Patients (ASH-BDNF)

April 20, 2026 updated by: Rina Nurul Qalbi, Hasanuddin University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was conducted at Dadi Psychiatric Hospital (RSKD Dadi), South Sulawesi Province, Makassar, Indonesia, in 2026.

BACKGROUND:

Schizophrenia is a chronic psychiatric disorder characterized by cognitive impairment and neurobiological alterations, including decreased levels of brain-derived neurotrophic factor (BDNF), which plays a key role in neuroplasticity and cognitive function. Standard treatment with antipsychotics such as risperidone improves psychotic symptoms but has limited effects on cognitive deficits. Ashwagandha (Withania somnifera), a medicinal plant with neuroprotective, anti-inflammatory, and antioxidant properties, has been proposed as an adjunctive therapy to improve cognitive function and increase BDNF levels. However, evidence regarding its effectiveness in schizophrenia remains limited.

INTERVENTION:

The intervention group received risperidone in standard therapeutic doses combined with Ashwagandha extract for 8 weeks. The control group received risperidone monotherapy for the same duration. Both groups continued standard clinical care throughout the study period.

RANDOMIZATION AND BLINDING:

Participants were allocated into two groups (intervention and control). Randomization was performed using the Sequentially Numbered Opaque Sealed Envelope (SNOSE) method, prepared by a separate research assistant and disclosed only after informed consent and baseline assessments were completed. The study employed a double-blind design in which both participants and outcome assessors were blinded to group allocation.

OUTCOME MEASURES:

The primary outcomes were: (1) change in cognitive function assessed using the Montreal Cognitive Assessment Indonesian version (MoCA-Ina) from baseline to Week 8; and (2) change in serum BDNF levels from baseline to Week 8. Secondary analysis included comparison of changes between groups and evaluation of the correlation between changes in MoCA-Ina scores and serum BDNF levels.

ETHICAL APPROVAL:

This study was approved by the Health Research Ethics Committee, Faculty of Medicine, Hasanuddin University, and conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent prior to enrollment.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Dadi Psychiatric Hospital (RSJ Dadi) Makassar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Participants receive risperidone combined with Ashwagandha extract for 8 weeks.
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.
Placebo Comparator: Control Group
Participants receive risperidone combined with a placebo for 8 weeks.
Drug: Risperidone 4mg/day
Participants receive risperidone in standard therapeutic doses as antipsychotic treatment for schizophrenia during the study period.
Other: Placebo
Placebo administered in combination with risperidone for 8 weeks in the control group, matched in appearance to Ashwagandha to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum BDNF levels
Time Frame: Baseline to Week 8
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)
Time Frame: Baseline to Week 8
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between changes in cognitive function scores and serum BDNF levels
Time Frame: Week 8
Correlation analysis between changes in Montreal Cognitive Assessment Indonesian Version (MoCA-Ina) total scores (range 0 to 30; higher scores indicate better cognitive function) and changes in serum brain-derived neurotrophic factor (BDNF) levels.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

Investigators

  • Principal Investigator: Rina Nurul Qalbi, MD, Hasanuddin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UH25070479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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