Effectiveness Of Individualised Homoeopathic Medicines In The Management Of Conduct Disorder With Supportive Counselling-A Double-Blind Randomised Placebo-Controlled Trial
试验速览
- 阶段
- 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
- To compare the Effectiveness of Individualized Homoeopathic Medicines In Reducing The
研究概览
简要总结
This study is a randomized, double blind, parallel group trial comparing Effectiveness Of Individualised Homoeopathic Medicines In The Management Of Conduct Disorder With Supportive Counselling-A Double-Blind Randomised Placebo-Controlled Trial that will be conducted in Outpatient department (OPD), Inpatient Department (IPD), and Peripheral camps under the Department of Psychiatry, NHRIMH, Kottayam. The primary outcome measures will be To compare the Effectiveness of Individualized Homoeopathic Medicines In Reducing The Disruptive Behavior In Conduct Disorder Using the Conduct Disorder Rating Scale (CDRS) Parent Version Comparing Outcomes with a Placebo every month. The secondary outcomes will be To find out the changes in the severity of conduct disorder using the Clinician Rated Severity Of Conduct Disorder and To evaluate the overall improvement of the conduct disorder by using the Clinical Global Improvement Scale every three months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 6-17 years of both genders.
- •Cases satisfying Conduct Disorder diagnostic criteria of DSM 5
- •Who is willing to provide informed written consent/assent form.
排除标准
- •Patients with antisocial personality disorder, ADHD, Intellectual Disability
- •Patients with organic psychosis.
- •Patients with pervasive developmental disorder
- •Known cases of uncontrolled Systemic illness
- •Substance-induced psychotic disorder.
结局指标
主要结局
To compare the Effectiveness of Individualized Homoeopathic Medicines In Reducing The
时间窗: every month from baseline till the conclusion of study(6th month)
Disruptive Behavior In Conduct Disorder Using the Conduct Disorder Rating Scale (CDRS)
时间窗: every month from baseline till the conclusion of study(6th month)
Parent Version Comparing Outcomes with Placebo.
时间窗: every month from baseline till the conclusion of study(6th month)
次要结局
- 1. To find out the changes in the severity of conduct disorder using the Clinician Rated Severity Of Conduct Disorder.(2. To evaluate the overall improvement of the conduct disorder by using the Clinical Global Improvement Scale.)
研究者
Dr Ramya V S
National Homoeopathy Institute in Mental Health