Effect of Curcumin Add-On Therapy on Quality of Life and IL-1β Levels in Patients With Schizophrenia (CUR-SCZ)

April 9, 2026 updated by: Rinvil Renaldi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90113
        • Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Presence of significant medical comorbidities
  • History of substance abuse within the past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risperidone Plus Curcumin
Participants receive risperidone 4 mg/day combined with curcumin extract 1000 mg/day administered orally for 8 weeks.
Dietary supplement: Curcumin
Curcumin extract 1000 mg/day administered orally as an adjuvant therapy in combination with risperidone for 8 weeks.
Other Names:
  • Turmeric extract
  • Curcuma longa extract
Drug: Risperidone 4mg/day
Risperidone 4 mg/day administered orally as standard antipsychotic therapy for 8 weeks.
Other Names:
  • Atypical antipsychotic
Active Comparator: Risperidone Alone
Participants receive risperidone 4 mg/day administered orally for 8 weeks.
Drug: Risperidone 4mg/day
Risperidone 4 mg/day administered orally as standard antipsychotic therapy for 8 weeks.
Other Names:
  • Atypical antipsychotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8
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.
Baseline, Week 4, and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rinvil Renaldi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Actual)

January 31, 2026

Study Completion (Actual)

January 31, 2026

Study Registration Dates

First Submitted

April 4, 2026

First Submitted That Met QC Criteria

April 4, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UH25100869

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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