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Completed

NCT Number: NCT07523256

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

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan

Makassar, South Sulawesi, 90113, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Curcumin

Dietary Supplement

Curcumin extract 1000 mg/day administered orally as an adjuvant therapy in combination with risperidone for 8 weeks.

Other names: Curcuma longa extract, Turmeric extract

Risperidone 4mg/day

Drug

Risperidone 4 mg/day administered orally as standard antipsychotic therapy for 8 weeks.

Other names: Atypical antipsychotic

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Rinvil Renaldi

Other

Registry information

Official study 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

Acronym: CUR-SCZ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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