The Efficacy of Individualized Homoeopathic Medicine in Improving the Self Esteem in Adolescent Depression- 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
- 152
- 试验地点
- 1
- 主要终点
- Change in score of self esteem by using Self Esteem Inventory Scale applied at base line 3 6 9 and 12 months in both arm
研究概览
简要总结
Depression is one of the leading causes of illness and disability among Adolescent population. One important aspect of depression is the Self- Esteem which plays a crucial role in shaping emotional resilience and coping the life challenges during this period. There were only limited studies conducted on this domain of adolescent depression in Homoeopathy. There is a time-demanding need for conducting an in-depth study on Self-esteem among the Adolescent population to explore new interventions to contain this challenge faced by the young population in our country. This proposed placebo-controlled RCT aims to investigate the efficacy of individualized homoeopathic medicine in improving the Self-esteem in Adolescent depression by using scales like SEI, BDI and WHO QOL. The findings of this study will be a new dimension in the management of Adolescent depression
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
- 10.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of both sexes ages from 10.00 to 19.oo years presenting with depressive symptoms as per ICD 11 criteria shall be screened with BDI and subjects scoring between 14 to 69 (mild to severe depression) shall be enrolled for the study.
排除标准
- •Cases currently under anti-depressant
- •Cases with medical or Surgical emergencies
- •BPAD cases with manic hypomanic and mixed states
- •Cases having significant suicide risk (ie attempt plan ideation etc) shall be screened by using
- •C-SSRS, either newly developed or not previously recognized.
结局指标
主要结局
Change in score of self esteem by using Self Esteem Inventory Scale applied at base line 3 6 9 and 12 months in both arm
时间窗: One year intervention period
次要结局
- Changes in the symptoms of adolescent depression by using Beck Depression Inventory Scale at base line 6 and 12 months
研究者
DR DHANARAJ KUMAR RANA
National Homoeopathy Research Institute in Mental Health Kottayam