Effectiveness of Individualized Homoeopathic Medicines in management of Depression, Anxiety & Stress in patients with non- communicable diseases A Multicentric 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
- 786
- 试验地点
- 4
- 主要终点
- To evaluate the effectiveness of individualized homoeopathic medicines in the management of Depression, Anxiety & Stress in patients with non-communicable diseases using DASS21 score post intervention
研究概览
简要总结
A multicentric randomized placebo- controlled trial will be conducted to evaluate the effectiveness of individualized homoeopathic medicines in the management of Depression, Anxiety & Stress in patients with Non-Communicable diseases(NCDs).
Diagnosed cases of NCDs on medication with Mild, Moderate & Severe score on DASS-21 Scale will be included. Change in the DASS-21 scale post intervention will be assessed. Secondary Objectives will be to assess Change in WHO QoL Bref Scale and Change in Depression, Anxiety & Stress and respective NCDs post intervention using validated scales and measures for each NCD.
In this Single Blind Randomized Controlled Trial, it is expected that individualized Homoeopathic medicines shall be effective in managing Depression, Anxiety and Stress in patients with Non-Communicable Diseases as compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Both genders and Age from 18 to 70 years.
- •Diagnosed cases of non-communicable diseases on medication.
- •Mild, Moderate & Severe cases on DASS-21 Scale.
- •Patients willing to participate in the study.
排除标准
- •Patients suffering from any other known psychiatric and neurocognitive disorders (except depression, anxiety and stress).
- •Patient under “extremely severe” category on DASS-21 score.
- •Patients with uncontrolled NCDs even after medication.
- •Patients suffering from communicable diseases like HIV,TB, Hepatitis, Leprosy etc.
- •Patients suffering from complications of NCDs like Diabetic retinopathy, diabetic neuropathy, diabetic nephropathy, Heart attack, Stroke, Acute limb ischaemia, acute respiratory distress syndrome, rheumatic heart disease, deep vein thrombosis, cor pulmonale, status asthmaticus, spontaneous pneumothorax, severe anaemia/neutropenia/sepsis/metastasis in cancer or any other Systemic diseases.
- •Pregnant and Lactating women.
结局指标
主要结局
To evaluate the effectiveness of individualized homoeopathic medicines in the management of Depression, Anxiety & Stress in patients with non-communicable diseases using DASS21 score post intervention
时间窗: Primary Outcome will be assessed at Baseline, after 2 weeks of Baseline and then every month for 6 months.
次要结局
- 1.To assess the changes in Quality of Life of patients using WHOQOL Bref Scale.(2.To assess the changes in Depression, Anxiety & Stress along with changes in respective NCDs using validated scales & measures.)
研究者
Dr Bharti Wadhwa
Central Council for Research in Homoeopathy