Schizophrenia PatientsASH-BDNFNCT07541157
Effect of Ashwagandha as Adjunct Therapy on BDNF and Cognitive Function in Schizophrenia Patients
A study testing Risperidone 4mg/day and Ashwagandha in people with Schizophrenia Patients, run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Schizophrenia Patients
- What is being tested?
- Risperidone 4mg/day and Ashwagandha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dadi Psychiatric Hospital (RSJ Dadi) Makassar
Makassar, South Sulawesi, 90245
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia Patients
- Being tested
- Risperidone 4mg/day, Ashwagandha, Placebo
- Keywords
- Ashwagandha, BDNF, Cognitive function, Adjunctive therapy, Risperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone 4mg/dayDrug
Participants receive risperidone in standard therapeutic doses as antipsychotic treatment for schizophrenia during the study period.
AshwagandhaDietary supplement
Ashwagandha extract (Withania somnifera) administered as adjunctive therapy in combination with risperidone 4mg/day for 8 weeks.
PlaceboOther
Placebo administered in combination with risperidone for 8 weeks in the control group, matched in appearance to Ashwagandha to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants receive risperidone combined with Ashwagandha extract for 8 weeks. Receives: Drug: Risperidone 4mg/day; Dietary Supplement: Ashwagandha |
| Control Group | Placebo comparator | Participants receive risperidone combined with a placebo for 8 weeks. Receives: Drug: Risperidone 4mg/day; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum BDNF levels
Serum brain-derived neurotrophic factor (BDNF) levels measured using laboratory analysis.
Measured: 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.
Measured: Baseline to Week 8
Secondary outcomes (1)
Correlation between changes in cognitive function scores and serum BDNF levels
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Sep 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rina Nurul Qalbi, Hasanuddin University
- Investigators
- Rina Nurul Qalbi, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541157
- Sponsor's protocol ID
- UH25070479
- Acronym
- ASH-BDNF
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07541157
- Acronym / sponsor ID
- ASH-BDNF / UH25070479
- Conditions
- Schizophrenia Patients
- Keywords
- Ashwagandha, BDNF, Cognitive function, Adjunctive therapy, Risperidone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Risperidone 4mg/day, Dietary Supplement: AshwagandhaParticipants receive risperidone combined with Ashwagandha extract for 8 weeks. |
| Control Group | Placebo comparator | Drug: Risperidone 4mg/day, Other: PlaceboParticipants receive risperidone combined with a placebo for 8 weeks. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risperidone 4mg/dayParticipants receive risperidone in standard therapeutic doses as antipsychotic treatment for schizophrenia during the study period. | Drug | Control Group, Intervention Group |
| AshwagandhaAshwagandha extract (Withania somnifera) administered as adjunctive therapy in combination with risperidone 4mg/day for 8 weeks. | Dietary supplement | Intervention Group |
| PlaceboPlacebo administered in combination with risperidone for 8 weeks in the control group, matched in appearance to Ashwagandha to maintain blinding. | Other | Control Group |
Primary outcome
Change in serum BDNF levels
Time frame: Baseline to Week 8
Serum brain-derived neurotrophic factor (BDNF) levels measured using laboratory analysis.
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.
1 secondary outcome
Correlation between changes in cognitive function scores and serum BDNF levels
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rina Nurul Qalbi, MD principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risperidone 4mg/day and Ashwagandha in people with Schizophrenia Patients, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum BDNF levels (time frame: Baseline to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.