Effect of Predefined Medicines of Calcarea Group in the Management of Global Developmental Delay in Children Under 5 years A Single Arm Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Assessing the Effect of Predefined Medicines of Calcarea group in the Management of Global Developmental Delay in Children Under 5 years using Vineland Social Maturity Scale
研究概览
简要总结
This Study aims to assess the effect of Predefined Medicines of Calcarea group in the management of Global Developmental Delay in children under 5 years of age in which 35 cases will be enrolled irrespective of gender and comorbidities and changes will be recorded using Vineland Social Maturity Scale and the commonly indicated medicine among predefined medicines of Calcarea group will be identified at the end of the treatment
For statistical analysis Repeated Measure ANOVA will be used at baseline 3 month and 6 month
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
- 6.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children under the age of 5 years irrespective of their gender diagnosed with Global Developmental Delay regardless of race caste religion or socioeconomic status Children diagnosed with Global Developmental Delay irrespective of having any other comorbidities.
排除标准
- •Children who are severely ill and require hospitalization Children with profound GDD SQ below 20 Children with uncontrolled or unstable psychiatric conditions that could affect participation in the study Children with severe or profound sensory and motor impairments e g total blindness or deafness that would impede the ability to participate in the study interventions or assessments Children who are currently involved in other clinical trials or interventions that might bias the outcomes of this study Children whose parents or guardians are unable to provide written informed consent or who do not comply with study requirements.
结局指标
主要结局
Assessing the Effect of Predefined Medicines of Calcarea group in the Management of Global Developmental Delay in Children Under 5 years using Vineland Social Maturity Scale
时间窗: 16 Months Study | 6 Months Enrollment | 6 Months Follow up | 2 Months Assessment and Data Analysis | 2 Months Report Writing | Scale to be assessed at baseline at 3 Month and at 6 Month
次要结局
未报告次要终点
研究者
Dr Preksha Gautam
Bakson Homoeopathic Medical College and Hospital36 B Knowledege Park 1 Greater Noida