Effectiveness of Individualized Homoeopathic Medicine in Cervical Lymphadenopathy in children- Pilot, Open label study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Change in number,location & size of the cervical lymph nodes
研究概览
简要总结
The multicentric, Pilot, Open-label, Interventional Study will be undertaken at the 4 peripheral units of CCRH with an objective to evaluate the effectiveness of individualized homeopathic medicine in cervical lymphadenopathy in children, to assess the change in number, location and size of the enlarged cervical lymph nodes , to assess the effectiveness of the individualized Homoeopathic medicines along with Silicea 6x (as a supportive medicine) and Tuberculinum 200 (as an intercurrent nosode) in children who are not responding to only individualized homoeopathic medicines/refractory cases of Tubercular Lymphadenitis. The outcome assessment parameters will be assessed every fortnightly by evaluating the change in number, location, size,mobility and consistency till end of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 5.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 5 to 17 years,Sex: Both male and female,Single or multiple enlarged cervical lymph nodes or enlarged unilateral or bilateral cervical lymph node, At least 1 cervical lymph node should be more than 1 cm or palpable,Assent of children and consent of parents.
排除标准
- •Children suffering from Pulmonary Tuberculosis, Hodgkin’s lymphoma, malignancy, autoimmune disease Children on Anti Tubercular Treatment (ATT) in the last 6 months.
- •Lymph node less than 1cm in size or at any other site such as inguinal or axillary areas.
结局指标
主要结局
Change in number,location & size of the cervical lymph nodes
时间窗: Assessed fortnightly till end of 6 months
次要结局
- Change in mobility(Change in consistency)