The efficacy of individualized homoeopathic medicines in the management of Major Depressive Disorder with supportive counseling- a double blind randomized placebo controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Hamilton Depression Rating Scale (HDRS) will be assessed every month. The outcome measurement will be done by comparing the Hamilton Depression Rating Scale scores of subjects of both group A and group B at baseline, 3rd month and 6th month
研究概览
简要总结
This study is conducted to determine the efficacy of individualized homoeopathic medicines in managing major depressive disorder as compared to placebo. Mild and moderate cases of depressive disorder will be taken. The primary outcome is to assess the changes in major depressive disorder using Hamilton Depression Rating Scale and secondary outcome is to find out the changes in quality of life using WHO QOL BREF at the end of 6 months. This study is one of its kind in terms of design and sample size. Hence this can be considered as the need of the hour to make a convincing and reliable statement to validate the efficacy of homoeopathy in treating major depressive disorder.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group between 18-60 yrs of both sexes
- •Patient presenting with symptoms of mild and moderate depressive disorder for at least 2 weeks duration and fulfilling the diagnostic criteria of DSM-V
- •Patients with Becks depression inventory score between 17-30.
排除标准
- •Patients having suicidal ideation with a history of attempted suicide.
- •Patients with severe depressive disorders taking anti depressants and antipsychotics.
- •Any other psychiatric co morbidities
- •Alcohol abuse/any serious physical illness using conventional treatment.
结局指标
主要结局
The Hamilton Depression Rating Scale (HDRS) will be assessed every month. The outcome measurement will be done by comparing the Hamilton Depression Rating Scale scores of subjects of both group A and group B at baseline, 3rd month and 6th month
时间窗: 6 months
次要结局
- The WHO QOL- BREF scale will be assessed at the baseline and 6th month of the study.(6 months)
研究者
DR K MADHAVI PRIYANKA
National Homoeopathy Research Institute in Mental Health