The Effect of Ashwagandha Therapy as an Adjunct on Serum BDNF Levels and Cognitive Function in Schizophrenia Patients Receiving Risperidone: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in serum BDNF levels
研究概览
简要总结
This study aims to evaluate the effectiveness of Ashwagandha (Withania somnifera) as an adjunctive therapy in improving serum brain-derived neurotrophic factor (BDNF) levels and cognitive function in patients with schizophrenia receiving risperidone treatment.
This study uses a controlled clinical trial design involving two groups: a control group receiving risperidone only and an intervention group receiving risperidone combined with Ashwagandha extract. Cognitive function is assessed using the Montreal Cognitive Assessment Indonesian version (MoCA-Ina), and serum BDNF levels are measured at baseline and after 8 weeks of treatment.
The study also aims to compare changes in cognitive function and BDNF levels between the two groups and to analyze the correlation between cognitive improvement and changes in BDNF levels. The findings are expected to provide evidence regarding the potential role of Ashwagandha as an adjunctive therapy for cognitive impairment in schizophrenia.
详细描述
This randomized controlled trial was conducted at Dadi Psychiatric Hospital (RSKD Dadi), South Sulawesi Province, Makassar, Indonesia, in 2026.
BACKGROUND:
Schizophrenia is a chronic psychiatric disorder characterized by cognitive impairment and neurobiological alterations, including decreased levels of brain-derived neurotrophic factor (BDNF), which plays a key role in neuroplasticity and cognitive function. Standard treatment with antipsychotics such as risperidone improves psychotic symptoms but has limited effects on cognitive deficits. Ashwagandha (Withania somnifera), a medicinal plant with neuroprotective, anti-inflammatory, and antioxidant properties, has been proposed as an adjunctive therapy to improve cognitive function and increase BDNF levels. However, evidence regarding its effectiveness in schizophrenia remains limited.
INTERVENTION:
The intervention group received risperidone in standard therapeutic doses combined with Ashwagandha extract for 8 weeks. The control group received risperidone monotherapy for the same duration. Both groups continued standard clinical care throughout the study period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study used a double-blind design in which participants and outcome assessors were blinded to group allocation. Investigators were also blinded to minimize bias.
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/PPDGJ III criteria
- •Aged 20-45 years
- •Duration of illness ≤ 5 years
- •Patients who have passed the acute phase (PANSS-EC < 15)
- •Receiving risperidone 4 mg/day
- •Willing to participate and provide written informed consent
排除标准
- •Presence of organic comorbid diseases
- •History of substance abuse (NAPZA) within the last 1 year, except caffeine and nicotine
- •Use of anti-inflammatory drugs, antibiotics, or antioxidant agents
- •Intellectual disability (mental retardation)
研究组 & 干预措施
Intervention Group
Participants receive risperidone combined with Ashwagandha extract for 8 weeks.
干预措施: Risperidone 4mg/day (Drug)
Intervention Group
Participants receive risperidone combined with Ashwagandha extract for 8 weeks.
干预措施: Ashwagandha (Dietary Supplement)
Control Group
Participants receive risperidone combined with a placebo for 8 weeks.
干预措施: Risperidone 4mg/day (Drug)
Control Group
Participants receive risperidone combined with a placebo for 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in serum BDNF levels
时间窗: Baseline to Week 8
Serum brain-derived neurotrophic factor (BDNF) levels measured using laboratory analysis.
Change in cognitive function (MoCA-Ina score)
时间窗: Baseline to Week 8
Cognitive function assessed using the Montreal Cognitive Assessment Indonesian version (MoCA-Ina).
次要结局
- Correlation between changes in MoCA-Ina score and BDNF levels(Week 8)
研究者
Rina Nurul Qalbi
MD
Hasanuddin University