A prospective study to assess the effect of individualized homoeopathic intervention in the treatment of depression among patients with Type 2 diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Intensity of depression measured by change in Patient Health Questionnaire-9 (PHQ-9) scores in patients with Type 2 Diabetes Mellitus receiving individualized homeopathic treatment.
研究概览
简要总结
Depression is a common psychological disorder marked by persistent low mood, loss of interest, decreased energy, and impaired functioning in daily life. It can arise from multiple causes, including biological, psychological, and social factors. In patients with Type 2 Diabetes Mellitus (T2DM), depression frequently develops as a comorbid condition due to the chronic nature of the disease, associated complications, lifestyle limitations, and continuous need for treatment. Depressive symptoms are seen among 30% of Type 2 Diabetes Mellitus patients, leading to poor treatment adherence and compromised glycemic control.
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
- 10.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed/ undiagnosed cases of depression as per the Patient Health Questionnaire (PHQ-9) with Type 2 Diabetes Mellitus, of all age groups, irrespective of their gender.
- •Patients who will give written consent and are willing to participate in the study.
排除标准
- •Patients suffering from severe depression, or other major psychiatric disorders, or with any severe diabetic complications.
- •Pregnant or breastfeeding women.
- •Patients who are not willing to give written consent for the study.
结局指标
主要结局
Intensity of depression measured by change in Patient Health Questionnaire-9 (PHQ-9) scores in patients with Type 2 Diabetes Mellitus receiving individualized homeopathic treatment.
时间窗: Baseline and during follow-up visits at 3 and 6 months.
次要结局
- Effectiveness of the homeopathic miasmatic approach assessed by improvement in clinical symptoms and depression scores.(Baseline and during follow-up visits at 3 and 6 months.)
研究者
Vimugdha Garg
Sri Ganganagar Homoeopathic Medical College Hospital and Research Institute