Comparative Study of Individualized Homoeopathy and Placebo Combined with Yoga in Managing Mild to Moderate Depressive Disorder among Adult Population: A Randomized, Placebo Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Changes will be observed on BDI-II Scale.
研究概览
简要总结
This study is to assess the role of Homoeopathic Medicine in the treatment of managing mild to moderate depressive disorder.
Sample size is 62.
Double arm Study,15 Months study.
Scale used for assessment Beck’s Depression Inventory Scale (BDI-II).
It is expected to see positive changes in the BDI-II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants included as per DSM-5 diagnostic criteria for depressive disorder.
- •All genders of an adult age group from 18 years to 59 years.
- •Participants who are ready to quit previous regimen.
排除标准
- •Any form of severe systemic illness and immunocompromised participants will be excluded.
- •Pregnant and lactating women.
- •Substance Abuse, Other Mood disorder and other severe psychiatric disorders will be excluded.
- •Participants who have taken any homoeopathic medicines in the past 3 months.
- •Participants who refuses to give consent.
- •Participants with severe and extreme depression will be excluded.
结局指标
主要结局
Changes will be observed on BDI-II Scale.
时间窗: 15 Months Study | 6 Months Enrollment | 6 Months Follow up | 3 Months Data Analysis | first dose at the time of case taking subsequent doses according to follow ups. | Beck’s Depression inventory scale to be used at the baseline and then 4 weeks,8 weeks,12 weeks upto 24 weeks.
Changes can be Positive, or Negative or No change.
时间窗: 15 Months Study | 6 Months Enrollment | 6 Months Follow up | 3 Months Data Analysis | first dose at the time of case taking subsequent doses according to follow ups. | Beck’s Depression inventory scale to be used at the baseline and then 4 weeks,8 weeks,12 weeks upto 24 weeks.
次要结局
- N/A(N/A)
研究者
Dr Aaskiran kaur
Bakson Homoeopathic Medical College and Hospital