Effectiveness of Ultra high dilution of Chlorpromazinum compared to Individualized Homoeopathic Medicine in reducing Positive symptoms of Schizophrenia - A Single Blind Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Assessment of reduction in positive symptoms of Schizophrenia using Scale for Assessment of Positive Symptoms, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.
研究概览
简要总结
The study is a Single Blind Randomized Controlled Trial conducted at the National Homeopathy Research Institute in Mental Health, Kottayam, with a duration of 18 months (12 months enrollment and 6 months follow-up). The primary objective is to compare the effectiveness of homoeopathic Chlorpromazinum with individualized homoeopathic medicine in reducing positive symptoms of schizophrenia. The primary outcome measure is the reduction in positive symptoms assessed by the SAPS (Scale for the Assessment of Positive Symptoms) score. Secondary outcome measures include evaluating the overall symptom reduction with PANSS (Positive and Negative Syndrome Scale) and assessing the effectiveness of homoeopathic medicine in mitigating side effects of antipsychotic medications using the Glasgow Anti-psychotics Side-effect Scale (GASS). Assessments are planned monthly with SAPS, at baseline and study endpoint with PANSS, and every three months with GASS. Monthly follow-ups will be conducted for up to 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of all genders
- •Ages between 18 and 65 years of age
- •Subjects fulfilling ICD 10 diagnostic criteria of Schizophrenia.
- •Patients under Antipsychotic medication.
排除标准
- •Patients with comorbid neuro-psychiatric disorders
- •Patients with serious systemic illness.
- •Pregnant and lactating women.
结局指标
主要结局
Assessment of reduction in positive symptoms of Schizophrenia using Scale for Assessment of Positive Symptoms, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.
时间窗: Every month from baseline till the conclusion of the study(6th month)
次要结局
- Assessment of overall improvement in the symptoms of Schizophrenia using Positive and Negative Syndrome Scale, after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.(At the baseline and end of the study(6th month))
- Assessment of reduction in the Side-effects of antipsychotic medications using Glasgow Anti-Psychotics Side-effect Scale after administration of Homoeopathic Chlorpromazinum and Individualized Homoeopathic Medicine in respective groups.(Baseline, at 3rd,and conclusion of the study(6th month))
研究者
Dr S Sudheer Kumar
National Homoeopathy Research Institute in Mental Health