Effectiveness of individualised Homoeopathic medicine in the management of affect in Schizophrenia- a single arm prospective study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Assessment of changes in the affect of schizophrenia
研究概览
简要总结
This study is an open label, single arm, clinical interventional study to determine the effectiveness of Individualized Homoeopathic Medicines in the management of affect in schizophrenia that will be conducted in OPD, IPD and Peripheral units of Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measures , improvement in positive affect and reduction in negative affect of schizophrenia; assessed using the Positive and Negative Affect Schedule (PANAS) Score at baseline,3rd month,6th month, and 12th month. The secondary outcome will be, improvement in the intensity of symptoms in patients with schizophrenia, after administration of individualized homoeopathic medicine using the PANSS Scale; assessed at baseline,3rd month,6th month, and 12th month by using the Positive and Negative Syndrome Scale (PANSS). As the study with the aforementioned domains is one of its kind, it aims to make the efforts offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicines in management of affect in schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who fulfill the diagnostic criteria for schizophrenia in ICD 10
- •Patients of ages from 19 to 65
- •Patients of all genders.
排除标准
- •Patients with substance-induced psychotic illness.
- •Other Mood disorders
- •Patients with life-threatening systemic illness.
- •Patients who are pregnant and lactating mothers.
结局指标
主要结局
Assessment of changes in the affect of schizophrenia
时间窗: 6 months for enrollment. One year for follow-up and intervention
after administering individualized Homoeopathic medicine is planned to be done 3rd 6th 9th and
时间窗: 6 months for enrollment. One year for follow-up and intervention
12th months by using the PANAS Scale
时间窗: 6 months for enrollment. One year for follow-up and intervention
次要结局
- Assessment of Improvement in the severity of illness of schizophrenia(after administering individualized Homoeopathic medicine is planned to be done 3rd 6th 9th and)
研究者
Dr Akshay V
National Homoeopathy Research Institute in Mental Health