Ashwagandha Added to Risperidone for Quality of Life and Inflammation in Schizophrenia
NCT07917637, Not applicable, Completed, Athitah Pratiwi
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Ashwagandha Added to Risperidone for Quality of Life and Inflammation in Schizophrenia | ClinicalTrials.gov |
| NCT number | NCT07917637 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 60 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Athitah Pratiwi | ClinicalTrials.gov |
| Conditions | Schizophrenia | ClinicalTrials.gov |
| Interventions | Withania somnifera (Ashwagandha) Extract, Risperidone 4mg/day, Placebo capsules | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Serum TNF-alpha Concentration From Baseline to Week 8 | 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. | ClinicalTrials.gov |
| Secondary | Change in Total SQLS-R4 Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change in Total BPRS Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change in SQLS-R4 Psychosocial Domain Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change in SQLS-R4 Cognition and Vitality Domain Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change in BPRS Affective Symptom Domain Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change in BPRS Positive Symptom Domain Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
| Secondary | Change in BPRS Negative Symptom Domain Score From Baseline to Week 8 | Baseline and 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 29995356 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)