SchizophreniaNCT07917637
Ashwagandha Added to Risperidone for Quality of Life and Inflammation in Schizophrenia
A study testing Withania somnifera (Ashwagandha) Extract and Risperidone 4mg/day in people with Schizophrenia, run by Athitah Pratiwi at 1 site in Indonesia.
Trial summary
Schizophrenia is a chronic mental health disorder that affects thinking, emotions, behavior, and quality of life. Although antipsychotic medications such as risperidone are commonly used to manage schizophrenia, some patients continue to experience psychiatric symptoms and reduced quality of life. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Withania somnifera (Ashwagandha) Extract and Risperidone 4mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Mar 2026to 30 Jun 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 aged 20-45 years.
- Diagnosed with schizophrenia according to the International Classification of Diseases, 10th Revision (ICD-10), and the Indonesian Classification and Diagnostic Guidelines for Mental Disorders III (PPDGJ-III).
- Duration of schizophrenia of five years or less since disease onset.
- Having passed the acute agitation phase, defined by a Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score below 15.
- Receiving risperidone at a dose of 4 mg/day.
- Able to read and write.
- Willing to participate and able to provide written informed consent.
Who cannot join
- Presence of organic medical comorbidities.
- Intellectual disability.
- History of substance use within the preceding six months, except caffeine or nicotine.
- Concurrent use of anti-inflammatory medications, antibiotics, or antioxidant supplements.
- Changes in antipsychotic treatment during the screening period.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan
Makassar, South Sulawesi, 90113
About this study
Official title: Effects of Adjunctive Ashwagandha Therapy on Clinical Symptoms, Quality of Life, and Serum TNF-α Levels in Patients With Schizophrenia Receiving Risperidone
Schizophrenia is a chronic mental health disorder that affects thinking, emotions, behavior, and quality of life. Although antipsychotic medications such as risperidone are commonly used to manage schizophrenia, some patients continue to experience psychiatric symptoms and reduced quality of life. Inflammation may also contribute to the development and severity of schizophrenia.
Ashwagandha (Withania somnifera) is a medicinal plant with potential anti-inflammatory and neuroprotective properties. This study evaluated whether adding ashwagandha to standard risperidone treatment could improve quality of life, reduce psychiatric symptoms, and lower blood levels of tumor necrosis factor-alpha (TNF-alpha), a marker of inflammation, in patients with schizophrenia.
Read more
This randomized, double-blind, placebo-controlled study included 60 male patients with schizophrenia aged 20 to 45 years. Participants were randomly assigned to receive either ashwagandha plus risperidone or placebo plus risperidone for eight weeks.
Quality of life, psychiatric symptoms, and blood levels of TNF-alpha were assessed at the beginning of the study and after eight weeks of treatment. The study aimed to provide additional evidence regarding the potential benefits of ashwagandha as an adjunctive treatment for schizophrenia.
Read the detailed description
This study was an eight-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted at Dadi Regional Special Hospital, South Sulawesi, Indonesia.
The study investigated the effects of adjunctive Withania somnifera (ashwagandha) on schizophrenia-specific quality of life, psychiatric symptom severity, and serum tumor necrosis factor-alpha (TNF-alpha) concentrations in patients receiving risperidone.
A total of 60 male patients aged 20-45 years with a diagnosis of schizophrenia according to ICD-10 and Indonesian psychiatric diagnostic guidelines (PPDGJ-III) were enrolled. Participants had an illness duration of no more than five years, had passed the acute phase of illness, and were receiving risperidone 4 mg/day.
Eligible participants were randomly allocated in a 1:1 ratio to one of two treatment groups:
- Intervention group: Risperidone 4 mg/day combined with standardized Withania somnifera extract 1,000 mg/day, administered orally as two 500-mg doses.
- Control group: Risperidone 4 mg/day combined with matching placebo capsules.
The standardized ashwagandha extract contained 5% withanolides. Treatment was administered for eight consecutive weeks. Participants and outcome assessors were blinded to treatment allocation.
Psychiatric symptoms were evaluated using the Brief Psychiatric Rating Scale (BPRS), including total scores and affective, positive, and negative symptom domains. Schizophrenia-specific quality of life was assessed using the Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4), including psychosocial and cognition-and-vitality domains.
Serum TNF-alpha concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). Clinical assessments and blood sampling were performed at baseline and week 8.
Treatment adherence and adverse events were monitored during the intervention period. The study also explored relationships among psychiatric symptom severity, quality of life, and serum TNF-alpha concentrations.
- Conditions
- Schizophrenia
- Being tested
- Withania somnifera (Ashwagandha) Extract, Risperidone 4mg/day, Placebo capsules
- Keywords
- Ashwagandha, Withania somnifera, Risperidone, Adjunctive therapy, Quality of life, TNF-alpha, Brief Psychiatric Rating Scale, Randomized controlled trial
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withania somnifera (Ashwagandha) ExtractDietary supplement
Also called Ashwagandha
Standardized Withania somnifera (ashwagandha) extract containing 5% withanolides, administered orally at a total dose of 1,000 mg/day (two 500-mg capsules) for eight weeks as an adjunct to risperidone 4 mg/day.
Risperidone 4mg/dayDrug
Oral risperidone administered at a fixed dose of 4 mg/day for eight weeks as standard antipsychotic treatment. Risperidone was administered to participants in both the ashwagandha and placebo groups.
Placebo capsulesDietary supplement
Also called Matching placebo
Matching placebo capsules without active ashwagandha extract, administered orally for eight weeks alongside risperidone 4 mg/day. The placebo capsules were matched to the ashwagandha capsules in appearance, including shape, color, and size.
| Study group | Role | What they receive |
|---|---|---|
| Ashwagandha Plus Risperidone | Experimental | Participants received risperidone 4 mg/day combined with standardized Withania somnifera (ashwagandha) extract 1,000 mg/day, administered orally in two divided doses of 500 mg for eight weeks. The ashwagandha extract contained 5% withanolides. Receives: Dietary Supplement: Withania somnifera (Ashwagandha) Extract; Drug: Risperidone 4mg/day |
| Placebo Plus Risperidone | Placebo comparator | Participants received risperidone 4 mg/day combined with matching placebo capsules administered orally for eight weeks. The placebo capsules were matched in appearance to the ashwagandha capsules. Receives: Drug: Risperidone 4mg/day; Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum TNF-alpha Concentration From Baseline to Week 8
Serum tumor necrosis factor-alpha (TNF-alpha) concentrations were measured using an enzyme-linked immunosorbent assay (ELISA) at baseline and week 8. Concentrations were expressed in pg/mL. Change was calculated as the week-8 value minus the baseline value. Negative values indicated a reduction in serum TNF-alpha concentration.
Measured: Baseline and Week 8
Secondary outcomes (7)
Change in Total SQLS-R4 Score From Baseline to Week 8
Schizophrenia-specific quality of life was assessed using the 33-item Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4). Total scores were transformed to a 0-100 scale, with higher scores indicating poorer quality of life. Change was calculated as the week-8 score minus the baseline score. Negative values indicated improvement in quality of life.
Measured: Baseline and Week 8
Change in Total BPRS Score From Baseline to Week 8
Overall psychiatric symptom severity was assessed using the 18-item Brief Psychiatric Rating Scale (BPRS). Each item was scored from 1 to 7, with a total score range of 18-126. Higher scores indicated greater psychiatric symptom severity. Change was calculated as the week-8 score minus the baseline score. Negative values indicated symptom improvement.
Measured: Baseline and Week 8
Change in SQLS-R4 Psychosocial Domain Score From Baseline to Week 8
The psychosocial domain of the SQLS-R4 comprises 22 items assessing psychosocial aspects of quality of life. Scores were transformed to a 0-100 scale, with higher scores indicating poorer quality of life. Change was calculated as the week-8 score minus the baseline score.
Measured: Baseline and Week 8
Change in SQLS-R4 Cognition and Vitality Domain Score From Baseline to Week 8
The cognition and vitality domain of the SQLS-R4 comprises 11 items assessing subjective cognition, energy, and vitality. Scores were transformed to a 0-100 scale, with higher scores indicating poorer quality of life. Change was calculated as the week-8 score minus the baseline score.
Measured: Baseline and Week 8
Change in BPRS Affective Symptom Domain Score From Baseline to Week 8
Affective symptoms were evaluated using BPRS items 1, 2, 5, and 9. Each item was rated from 1 to 7, resulting in a domain score range of 4-28. Higher scores indicated greater symptom severity. Change was calculated as the week-8 score minus the baseline score.
Measured: Baseline and Week 8
Change in BPRS Positive Symptom Domain Score From Baseline to Week 8
Positive symptoms were evaluated using BPRS items 4, 11, 12, and 15. Each item was rated from 1 to 7, resulting in a domain score range of 4-28. Higher scores indicated greater symptom severity. Change was calculated as the week-8 score minus the baseline score.
Measured: Baseline and Week 8
Change in BPRS Negative Symptom Domain Score From Baseline to Week 8
Negative symptoms were evaluated using BPRS items 3, 13, and 16. Each item was rated from 1 to 7, resulting in a domain score range of 3-21. Higher scores indicated greater symptom severity. Change was calculated as the week-8 score minus the baseline score.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start13 Mar 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athitah Pratiwi
- Sponsor type
- University, hospital or other
- Collaborators
- Hasanuddin University
- Responsible party
- Sponsor-investigator, Athitah Pratiwi, Hasanuddin University
- Investigators
- Athitah Pratiwi, Medical Doctor, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917637
- Sponsor's protocol ID
- ATHITAH-ASH-2026-01
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published study results, including treatment allocation, baseline and week-8 SQLS-R4 scores, BPRS scores, and serum TNF-alpha concentrations, may be shared with qualified researchers upon reasonable request. Data sharing will be subject to ethical approval, institutional regulations, and participant confidentiality requirements. Identifiable participant information will not be shared.
Publications
Chengappa KNR, Brar JS, Gannon JM, Schlicht PJ. Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2018 Jul 10;79(5):17m11826. doi: 10.4088/JCP.17m11826.
PubMed 29995356
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adjunctive Ashwagandha Therapy on Clinical Symptoms, Quality of Life, and Serum TNF-α Levels in Patients With Schizophrenia Receiving Risperidone
- ClinicalTrials.gov ID
- NCT07917637
- Acronym / sponsor ID
- ATHITAH-ASH-2026-01
- Conditions
- Schizophrenia
- Keywords
- Ashwagandha, Withania somnifera, Risperidone, Adjunctive therapy, Quality of life, TNF-alpha, Brief Psychiatric Rating Scale, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Athitah PratiwiUniversity, hospital or other
- Collaborators
- Hasanuddin University
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 4 Nov 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.
Schizophrenia is a chronic mental health disorder that affects thinking, emotions, behavior, and quality of life. Although antipsychotic medications such as risperidone are commonly used to manage schizophrenia, some patients continue to experience psychiatric symptoms and reduced quality of life. Inflammation may also contribute to the development and severity of schizophrenia.
Ashwagandha (Withania somnifera) is a medicinal plant with potential anti-inflammatory and neuroprotective properties. This study evaluated whether adding ashwagandha to standard risperidone treatment could improve quality of life, reduce psychiatric symptoms, and lower blood levels of tumor necrosis factor-alpha (TNF-alpha), a marker of inflammation, in patients with schizophrenia.
This randomized, double-blind, placebo-controlled study included 60 male patients with schizophrenia aged 20 to 45 years. Participants were randomly assigned to receive either ashwagandha plus risperidone or placebo plus risperidone for eight weeks.
Quality of life, psychiatric symptoms, and blood levels of TNF-alpha were assessed at the beginning of the study and after eight weeks of treatment. The study aimed to provide additional evidence regarding the potential benefits of ashwagandha as an adjunctive treatment for schizophrenia.
Detailed description
This study was an eight-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted at Dadi Regional Special Hospital, South Sulawesi, Indonesia.
The study investigated the effects of adjunctive Withania somnifera (ashwagandha) on schizophrenia-specific quality of life, psychiatric symptom severity, and serum tumor necrosis factor-alpha (TNF-alpha) concentrations in patients receiving risperidone.
A total of 60 male patients aged 20-45 years with a diagnosis of schizophrenia according to ICD-10 and Indonesian psychiatric diagnostic guidelines (PPDGJ-III) were enrolled. Participants had an illness duration of no more than five years, had passed the acute phase of illness, and were receiving risperidone 4 mg/day.
Eligible participants were randomly allocated in a 1:1 ratio to one of two treatment groups:
- Intervention group: Risperidone 4 mg/day combined with standardized Withania somnifera extract 1,000 mg/day, administered orally as two 500-mg doses.
- Control group: Risperidone 4 mg/day combined with matching placebo capsules.
The standardized ashwagandha extract contained 5% withanolides. Treatment was administered for eight consecutive weeks. Participants and outcome assessors were blinded to treatment allocation.
Psychiatric symptoms were evaluated using the Brief Psychiatric Rating Scale (BPRS), including total scores and affective, positive, and negative symptom domains. Schizophrenia-specific quality of life was assessed using the Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4), including psychosocial and cognition-and-vitality domains.
Serum TNF-alpha concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). Clinical assessments and blood sampling were performed at baseline and week 8.
Treatment adherence and adverse events were monitored during the intervention period. The study also explored relationships among psychiatric symptom severity, quality of life, and serum TNF-alpha concentrations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ashwagandha Plus Risperidone | Experimental | Dietary Supplement: Withania somnifera (Ashwagandha) Extract, Drug: Risperidone 4mg/dayParticipants received risperidone 4 mg/day combined with standardized Withania somnifera (ashwagandha) extract 1,000 mg/day, administered orally in two divided doses of 500 mg for eight weeks. The ashwagandha extract contained 5% withanolides. |
| Placebo Plus Risperidone | Placebo comparator | Drug: Risperidone 4mg/day, Dietary Supplement: Placebo capsulesParticipants received risperidone 4 mg/day combined with matching placebo capsules administered orally for eight weeks. The placebo capsules were matched in appearance to the ashwagandha capsules. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male patients aged 20-45 years.
- Diagnosed with schizophrenia according to the International Classification of Diseases, 10th Revision (ICD-10), and the Indonesian Classification and Diagnostic Guidelines for Mental Disorders III (PPDGJ-III).
- Duration of schizophrenia of five years or less since disease onset.
- Having passed the acute agitation phase, defined by a Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) score below 15.
- Receiving risperidone at a dose of 4 mg/day.
Key exclusion criteria (5 listed)
- Presence of organic medical comorbidities.
- Intellectual disability.
- History of substance use within the preceding six months, except caffeine or nicotine.
- Concurrent use of anti-inflammatory medications, antibiotics, or antioxidant supplements.
- Changes in antipsychotic treatment during the screening period.
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 |
|---|---|---|
| Withania somnifera (Ashwagandha) ExtractAlso: AshwagandhaStandardized Withania somnifera (ashwagandha) extract containing 5% withanolides, administered orally at a total dose of 1,000 mg/day (two 500-mg capsules) for eight weeks as an adjunct to risperidone 4 mg/day. | Dietary supplement | Ashwagandha Plus Risperidone |
| Risperidone 4mg/dayOral risperidone administered at a fixed dose of 4 mg/day for eight weeks as standard antipsychotic treatment. Risperidone was administered to participants in both the ashwagandha and placebo groups. | Drug | Ashwagandha Plus Risperidone, Placebo Plus Risperidone |
| Placebo capsulesAlso: Matching placeboMatching placebo capsules without active ashwagandha extract, administered orally for eight weeks alongside risperidone 4 mg/day. The placebo capsules were matched to the ashwagandha capsules in appearance, including shape, color, and size. | Dietary supplement | Placebo Plus Risperidone |
Primary outcome
Change in Serum TNF-alpha Concentration From Baseline to Week 8
Time frame: Baseline and Week 8
Serum tumor necrosis factor-alpha (TNF-alpha) concentrations were measured using an enzyme-linked immunosorbent assay (ELISA) at baseline and week 8. Concentrations were expressed in pg/mL. Change was calculated as the week-8 value minus the baseline value. Negative values indicated a reduction in serum TNF-alpha concentration.
7 secondary outcomes
Change in Total SQLS-R4 Score From Baseline to Week 8
Time frame: Baseline and Week 8
Change in Total BPRS Score From Baseline to Week 8
Time frame: Baseline and Week 8
Change in SQLS-R4 Psychosocial Domain Score From Baseline to Week 8
Time frame: Baseline and Week 8
Change in SQLS-R4 Cognition and Vitality Domain Score From Baseline to Week 8
Time frame: Baseline and Week 8
Change in BPRS Affective Symptom Domain Score From Baseline to Week 8
Time frame: Baseline and Week 8
Change in BPRS Positive Symptom Domain Score From Baseline to Week 8
Time frame: Baseline and Week 8
Change in BPRS Negative Symptom Domain Score From Baseline to Week 8
Time frame: Baseline and 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 4 Nov 2026.
- Background: PubMed 29995356Chengappa KNR, Brar JS, Gannon JM, Schlicht PJ. Adjunctive Use of a Standardized Extract of Withania somnifera (Ashwagandha) to Treat Symptom Exacerbation in Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2018 Jul 10;79(5):17m11826. doi: 10.4088/JCP.17m11826.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published study results, including treatment allocation, baseline and week-8 SQLS-R4 scores, BPRS scores, and serum TNF-alpha concentrations, may be shared with qualified researchers upon reasonable request. Data sharing will be subject to ethical approval, institutional regulations, and participant confidentiality requirements. Identifiable participant information will not be shared.
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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.
Athitah Pratiwi, Medical Doctor 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 Withania somnifera (Ashwagandha) Extract and Risperidone 4mg/day in people with Schizophrenia, run by Athitah Pratiwi 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 7 inclusion and 5 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 4 Nov 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 TNF-alpha Concentration From Baseline to Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07917637, which also lists 1 linked publication.
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 4 Nov 2026.