An interventional study of Withania somnifera (Ashwagandha) Extract and Risperidone 4mg/day in Schizophrenia, sponsored by Athitah Pratiwi. Completed at 1 site in Indonesia. Open to male participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Athitah Pratiwi · Not applicable, Interventional, and Treatment
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.
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:
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 60 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with Athitah Pratiwi as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Withania somnifera (Ashwagandha) Extract · Drug: Risperidone 4mg/day
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.
Drug: Risperidone 4mg/day · Dietary Supplement: Placebo capsules
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.
Also known as: Ashwagandha
Drug page: Risperidone
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.
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.
Also known as: Matching placebo
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.
Time frame: Baseline and Week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 8
Plan to share: 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.
Supporting information: Study protocol
Time frame: De-identified individual participant data may be requested following publication of the primary study results and will remain available for the duration permitted by applicable institutional data-retention policies.
Access criteria: Qualified researchers may request access to de-identified individual participant data by contacting the corresponding author. Requests must include the research objectives, proposed analysis plan, and institutional affiliation. Access will be evaluated on a case-by-case basis and granted only when consistent with ethical approval, institutional data-sharing policies, and participant confidentiality requirements.
Ran from Mar 2026 to primary completion in Jun 2026, 3 months.
Of 753 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 3 months is below that.
Counting every sponsor, half of 766 studies reached it within 32 months; a quarter within 16 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ashwagandha