Role 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
- 1
- 主要终点
- Changes in the number and size of the cervical lymph nodes will be assessed monthly till the end of treatment.
研究概览
简要总结
This is a Pilot, Open-label, Interventional study and will be undertaken at the Homoeopathic Treatment centre (OPD),Safdarjung Hospital with an objective to evaluate the effectiveness of individualized homoeopathic medicine in cervical lymphadenopathy in children. The objective is to assess the change in number, location and size of the enlarged cervical lymph nodes. The outcome assessment parameters will be assessed monthly 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
- Na
- 盲法
- None
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, severe pathological changes like matting, ulceration, or abscess formation etc.
- •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
Changes in the number and size of the cervical lymph nodes will be assessed monthly till the end of treatment.
时间窗: Assessed monthly till end of 6 months
Change in mobility will be assessed monthly till the end of treatment.
时间窗: Assessed monthly till end of 6 months
Change in consistency will be assessed monthly till the end of treatment.
时间窗: Assessed monthly till end of 6 months
次要结局
- Change in mobility(Change in consistency)
研究者
Dr Renu Mittal
Central Council for Research in Homoeopathy