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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Serum Interleukin-1 Beta (IL-1β) Levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of significant medical comorbidities
- •History of substance abuse within the past 6 months
研究组 & 干预措施
Risperidone Plus Curcumin
Participants receive risperidone 4 mg/day combined with curcumin extract 1000 mg/day administered orally for 8 weeks.
干预措施: Risperidone 4mg/day (Drug)
Risperidone Alone
Participants receive risperidone 4 mg/day administered orally for 8 weeks.
干预措施: Risperidone 4mg/day (Drug)
Risperidone Plus Curcumin
Participants receive risperidone 4 mg/day combined with curcumin extract 1000 mg/day administered orally for 8 weeks.
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Change in Serum Interleukin-1 Beta (IL-1β) Levels
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Rinvil Renaldi
Principal Investigator
Hasanuddin University