Effectiveness of Individualized Homoeopathic Medicines in the management of Substance-Induced Psychotic Disorder – An Open-Label Single-Arm 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 the reduction of the severity of symptoms of participants with substance-induced psychotic disorder after the administration of Individualized Homoeopathic Medicines is planned to be done using the Brief Psychiatric Rating Scale (BPRS).
研究概览
简要总结
This open label, single arm, clinical interventional study, aims to investigate whether Individualized Homeopathic Medicine can effectively reduce symptoms associated with substance-induced psychotic disorder (SIPD). SIPD is a condition where individuals experience delusions and hallucinations as a result of substance use. Currently, there is limited research on specific treatments for SIPD, and conventional treatments often focus on managing symptoms rather than addressing the underlying causes. Homeopathy, which takes a holistic approach to health, offers a potential alternative.
The research team plans to enroll 35 participants aged 18 to 60 who have symptoms of SIPD. Participants will undergo detailed screening and assessment to confirm the diagnosis and ensure they meet the study criteria. Those eligible will receive individualized homeopathic treatment based on their unique symptoms, as determined through comprehensive case-taking and analysis.
The severity of participants’ symptoms will be assessed using the Brief Psychiatric Rating Scale (BPRS) at the beginning of the study and regularly throughout the 12-month follow-up period. Additionally, changes in participants’ quality of life will be measured using the World Health Organization Quality of Life (WHOQOL-BREF) scale.
The research team will closely monitor participants’ progress and adjust treatment as needed. Participants who experience adverse reactions or serious events will receive appropriate support and care. To maintain ethical standards, informed consent will be obtained from all participants, and confidentiality will be strictly maintained.
By the end of the study, the researchers aim to determine if Individualized Homeopathic Medicine leads to a significant reduction in SIPD symptoms and improves participants’ quality of life. If successful, this research could provide valuable insights into alternative treatment options for SIPD and potentially reduce the burden of this condition on individuals and society.
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
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of both genders between the ages of 18 to
- •Patients presenting with Psychotic symptoms due to substance use.
- •BPRS score of 18 or more.
排除标准
- •Suicidal ideation.
- •Life-threatening serious systemic illness.
- •Pregnant and lactating women.
- •Primary psychotic disorders.
- •Psychotic disorder due to another medical condition.
结局指标
主要结局
Assessment of the reduction of the severity of symptoms of participants with substance-induced psychotic disorder after the administration of Individualized Homoeopathic Medicines is planned to be done using the Brief Psychiatric Rating Scale (BPRS).
时间窗: Every month from baseline till the 9th month
次要结局
- Assessment of the changes in quality of life of participants with substance-induced psychotic disorder after the administration of Individualized Homoeopathic Medicines is planned to be done using the World Health Organization Quality of Life (WHO-BREF-QoL) scale.(At the baseline & at the 9th month)
研究者
Dr M Selvaganapathi
National Homoeopathy Research Institute in Mental Health, Kottayam
