SchizophreniaCUR-SCZNCT07523256
Effect of Curcumin Add-On Therapy on Quality of Life and IL-1β Levels in Patients With Schizophrenia
A study testing Curcumin and Risperidone 4mg/day in people with Schizophrenia and Psychotic Disorders, run by Rinvil Renaldi at 1 site in Indonesia.
Trial summary
This study aims to evaluate the effect of curcumin extract as an adjuvant therapy on quality of life and inflammatory markers in patients with schizophrenia receiving risperidone. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- Curcumin and Risperidone 4mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 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 criteria
- Age between 20 and 45 years
- Insight level of 4
- Disease onset less than 12 months
- Post-acute phase with PANSS-EC score < 15
- Receiving risperidone 4 mg/day
- Willing to participate and provide informed consent
Who cannot join
- Presence of significant medical comorbidities
- History of substance abuse within the past 6 months
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: The Effect of Adjuvant Curcumin Extract on Quality of Life and Interleukin-1 Beta (IL-1β) Levels in Patients With Schizophrenia Receiving Risperidone: A Randomized Clinical Trial
This study aims to evaluate the effect of curcumin extract as an adjuvant therapy on quality of life and inflammatory markers in patients with schizophrenia receiving risperidone. Schizophrenia is associated with impaired quality of life and increased inflammatory activity, including elevated levels of interleukin-1 beta (IL-1β).
In this randomized clinical trial, patients with schizophrenia are assigned to receive either risperidone alone or risperidone combined with curcumin extract for 8 weeks. Quality of life is assessed using the WHOQOL-BREF questionnaire, and serum IL-1β levels are measured at baseline and after the intervention.
The study investigates whether curcumin, known for its anti-inflammatory and antioxidant properties, can improve clinical outcomes and reduce systemic inflammation in patients with schizophrenia.
Read the detailed description
Schizophrenia is a chronic psychiatric disorder characterized by cognitive impairment, social dysfunction, and reduced quality of life. Emerging evidence suggests that neuroinflammation plays a significant role in the pathophysiology of schizophrenia, with elevated levels of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β) observed in patients.
Curcumin, a bioactive compound derived from Curcuma longa, has demonstrated anti-inflammatory, antioxidant, and neuroprotective properties. It has been shown to modulate inflammatory pathways, including inhibition of nuclear factor-kappa B (NF-κB), and may reduce cytokine production. These properties suggest that curcumin could serve as a potential adjunctive therapy in schizophrenia.
This study is a randomized clinical trial conducted at Rumah Sakit Khusus Daerah (RSKD) Dadi, South Sulawesi, Indonesia. Participants diagnosed with schizophrenia according to ICD-10 criteria and receiving risperidone therapy are randomly assigned into two groups: (1) a control group receiving risperidone alone, and (2) an intervention group receiving risperidone combined with curcumin extract (1000 mg/day) for 8 weeks.
Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) instrument at baseline, week 4, and week 8. Serum IL-1β levels are measured at baseline and week 8 using enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study is to determine the effect of curcumin as an adjuvant therapy on quality of life and IL-1β levels in patients with schizophrenia. Secondary analyses include comparisons of changes between groups and evaluation of the correlation between inflammatory markers and quality of life outcomes.
This study is expected to provide evidence on the role of curcumin as a safe and effective adjunctive therapy targeting inflammatory pathways to improve clinical outcomes in schizophrenia.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- Curcumin, Risperidone 4mg/day
- Keywords
- Curcumin, IL-1β, Quality of Life, WHOQOL-BREF, Risperidone, Inflammation, Adjunct Therapy
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called Curcuma longa extract, Turmeric extract
Curcumin extract 1000 mg/day administered orally as an adjuvant therapy in combination with risperidone for 8 weeks.
Risperidone 4mg/dayDrug
Also called Atypical antipsychotic
Risperidone 4 mg/day administered orally as standard antipsychotic therapy for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Risperidone Plus Curcumin | Experimental | Participants receive risperidone 4 mg/day combined with curcumin extract 1000 mg/day administered orally for 8 weeks. Receives: Dietary Supplement: Curcumin; Drug: Risperidone 4mg/day |
| Risperidone Alone | Active comparator | Participants receive risperidone 4 mg/day administered orally for 8 weeks. Receives: Drug: Risperidone 4mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Interleukin-1 Beta (IL-1β) Levels
Serum IL-1β levels are measured using ELISA and expressed in pg/mL. Change from baseline to week 8 is evaluated.
Measured: Baseline and Week 8
Change in Quality of Life (WHOQOL-BREF Score)
Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), Indonesian version. The instrument consists of 26 items and evaluates four domains: physical health, psychological well-being, social relationships, and environment. Scores are transformed to a scale of 0-100, where higher scores indicate better quality of life. Changes from baseline to week 4 and week 8 are evaluated.
Measured: Baseline, Week 4, 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 posted13 Apr 2026
- Study start1 Nov 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 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
- Model description
- Participants are randomized into two parallel groups: one receiving risperidone plus curcumin extract and the other receiving risperidone alone for 8 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rinvil Renaldi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rinvil Renaldi, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523256
- Sponsor's protocol ID
- UH25100869
- Acronym
- CUR-SCZ
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) are not planned to be publicly shared; however, de-identified data may be made available upon reasonable request and with appropriate ethical and institutional approvals.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adjuvant Curcumin Extract on Quality of Life and Interleukin-1 Beta (IL-1β) Levels in Patients With Schizophrenia Receiving Risperidone: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07523256
- Acronym / sponsor ID
- CUR-SCZ / UH25100869
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Curcumin, IL-1β, Quality of Life, WHOQOL-BREF, Risperidone, Inflammation, Adjunct Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Rinvil RenaldiUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 13 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 effect of curcumin extract as an adjuvant therapy on quality of life and inflammatory markers in patients with schizophrenia receiving risperidone. Schizophrenia is associated with impaired quality of life and increased inflammatory activity, including elevated levels of interleukin-1 beta (IL-1β).
In this randomized clinical trial, patients with schizophrenia are assigned to receive either risperidone alone or risperidone combined with curcumin extract for 8 weeks. Quality of life is assessed using the WHOQOL-BREF questionnaire, and serum IL-1β levels are measured at baseline and after the intervention.
The study investigates whether curcumin, known for its anti-inflammatory and antioxidant properties, can improve clinical outcomes and reduce systemic inflammation in patients with schizophrenia.
Detailed description
Schizophrenia is a chronic psychiatric disorder characterized by cognitive impairment, social dysfunction, and reduced quality of life. Emerging evidence suggests that neuroinflammation plays a significant role in the pathophysiology of schizophrenia, with elevated levels of pro-inflammatory cytokines such as interleukin-1 beta (IL-1β) observed in patients.
Curcumin, a bioactive compound derived from Curcuma longa, has demonstrated anti-inflammatory, antioxidant, and neuroprotective properties. It has been shown to modulate inflammatory pathways, including inhibition of nuclear factor-kappa B (NF-κB), and may reduce cytokine production. These properties suggest that curcumin could serve as a potential adjunctive therapy in schizophrenia.
This study is a randomized clinical trial conducted at Rumah Sakit Khusus Daerah (RSKD) Dadi, South Sulawesi, Indonesia. Participants diagnosed with schizophrenia according to ICD-10 criteria and receiving risperidone therapy are randomly assigned into two groups: (1) a control group receiving risperidone alone, and (2) an intervention group receiving risperidone combined with curcumin extract (1000 mg/day) for 8 weeks.
Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) instrument at baseline, week 4, and week 8. Serum IL-1β levels are measured at baseline and week 8 using enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study is to determine the effect of curcumin as an adjuvant therapy on quality of life and IL-1β levels in patients with schizophrenia. Secondary analyses include comparisons of changes between groups and evaluation of the correlation between inflammatory markers and quality of life outcomes.
This study is expected to provide evidence on the role of curcumin as a safe and effective adjunctive therapy targeting inflammatory pathways to improve clinical outcomes in schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomized into two parallel groups: one receiving risperidone plus curcumin extract and the other receiving risperidone alone for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Risperidone Plus Curcumin | Experimental | Dietary Supplement: Curcumin, Drug: Risperidone 4mg/dayParticipants receive risperidone 4 mg/day combined with curcumin extract 1000 mg/day administered orally for 8 weeks. |
| Risperidone Alone | Active comparator | Drug: Risperidone 4mg/dayParticipants receive risperidone 4 mg/day administered orally for 8 weeks. |
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 diagnosed with schizophrenia based on ICD-10 criteria
- Age between 20 and 45 years
- Insight level of 4
- Disease onset less than 12 months
- Post-acute phase with PANSS-EC score < 15
Key exclusion criteria (2 listed)
- Presence of significant medical comorbidities
- History of substance abuse within the past 6 months
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 |
|---|---|---|
| CurcuminAlso: Curcuma longa extract, Turmeric extractCurcumin extract 1000 mg/day administered orally as an adjuvant therapy in combination with risperidone for 8 weeks. | Dietary supplement | Risperidone Plus Curcumin |
| Risperidone 4mg/dayAlso: Atypical antipsychoticRisperidone 4 mg/day administered orally as standard antipsychotic therapy for 8 weeks. | Drug | Risperidone Alone, Risperidone Plus Curcumin |
Primary outcome
Change in Serum Interleukin-1 Beta (IL-1β) Levels
Time frame: Baseline and Week 8
Serum IL-1β levels are measured using ELISA and expressed in pg/mL. Change from baseline to week 8 is evaluated.
Change in Quality of Life (WHOQOL-BREF Score)
Time frame: Baseline, Week 4, and Week 8
Quality of life is assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), Indonesian version. The instrument consists of 26 items and evaluates four domains: physical health, psychological well-being, social relationships, and environment. Scores are transformed to a scale of 0-100, where higher scores indicate better quality of life. Changes from baseline to week 4 and week 8 are evaluated.
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) are not planned to be publicly shared; however, de-identified data may be made available upon reasonable request and with appropriate ethical and institutional approvals.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin and Risperidone 4mg/day in people with Schizophrenia and Psychotic Disorders, run by Rinvil Renaldi 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 2 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 14 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. 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 Interleukin-1 Beta (IL-1β) Levels (time frame: Baseline and 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 14 Apr 2026.