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

NCT07523256 | Completed

• 1 other identifier: UH25100869
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

Curcumin; IL-1β; Quality of Life; WHOQOL-BREF; Risperidone; Inflammation; Adjunct Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 4, and Week 8

Study Arms (2)

Risperidone Plus Curcumin

EXPERIMENTAL

Participants receive risperidone 4 mg/day combined with curcumin extract 1000 mg/day administered orally for 8 weeks.

Dietary Supplement: Curcumin; Drug: Risperidone 4mg/day

Risperidone Alone

ACTIVE COMPARATOR

Participants receive risperidone 4 mg/day administered orally for 8 weeks.

Drug: Risperidone 4mg/day

Interventions

Risperidone 4mg/day DRUG

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

Also known as: Atypical antipsychotic

Risperidone Alone; Risperidone Plus Curcumin

Curcumin DIETARY_SUPPLEMENT

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

Also known as: Curcuma longa extract, Turmeric extract

Risperidone Plus Curcumin

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rinvil Renaldi: lead

Study Sites (1)

Rumah Sakit Khusus Daerah (RSKD) Dadi Provinsi Sulawesi Selatan

Makassar, South Sulawesi, 90113, Indonesia

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Inflammation

Interventions

Curcumin; turmeric extract; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is single-blind, where participants are not aware of their group allocation. Investigators are aware of the assigned interventions to ensure proper clinical monitoring.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized into two parallel groups: one receiving risperidone plus curcumin extract and the other receiving risperidone alone for 8 weeks.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: November 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

ID (1)