跳至主要内容
临床试验/CTRI/2023/06/053628
CTRI/2023/06/053628尚未招募2/3 期

Clinical Study To Evaluate The Combined Effect Of Panchagavya Ghrita And Selected Ayurveda Treatment Modality As An Early Intervention In The Management Of Global Developmental Delay.

DR ANJITH C BABU1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年6月18日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Improvements in attainment of age-appropriate developmental milestones after intervention which were delayed during the initial assessment will be re- assessed using DASII ( Developmental Assessment Scale For Indian Infants)

研究概览

简要总结

Global developmental delay is one of the major issues of concern during the early childhood which is unnoticed due to lack of early screening. The prevalence of Global developmental delay in children under 2 years of age in India is 1.5 to 2.5 % among the live births1.Growth and development occurs simultaneously as a continuous process. Growth denotes the quantitative increase in the cell mass whereas Development is the gradual and systematic maturation of the nervous system. Maturity of the central nervous system, which is very much essential for a child to learn particular skill or to achieve a milestone. Growth being a quantitative parameter, growth retardations are identified at the earliest. Whereas normal developmental pattern is assessed using different developmental milestones, which are unnoticed due to lack of awareness and tendency to pretend it as normal even if there is lag or delay. Global developmental delay can be defined as the failure to attain the age-appropriate developmental milestones in 2 or more domains of development. Development depends on the functional maturation of the nervous system. As the brain matures, certain primitive reflexes are lost and specific milestones are achieved. If the primitive reflexes are persisting beyond the expected age of regression, it is an early indicator for developmental delay. Previous studies suggest that early screening, identification and early intervention has shown considerable improvement in the condition2. Stimulation through Ayurveda procedures as an early intervention is a new ray of hope for a healthy future among the kids with developmental delay. Masthishka abhighata can be considered as one among the cause for developmental delay. In Bhaishajyaratnavali in the context of Mastishkachayaapachaya, Panchagavya ghrita is mentionedas Rasayana3. Hence the present study is planned to evaluate the effect of administration of Panchagavya ghrita in various forms (Basthi, Pratimarsha nasya & oral intake) as an early intervention along with external stimulation procedures like Sarvanga abhyanga and Parisheka.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
6.00 Month(s) 至 2.00 Year(s)(—)
性别
All

入选标准

  • 1.Children between the age group of 6 months to 24 months irrespective gender fulfilling the diagnostic criteria(DEVELOPMENTAL ASSESSMENT SCALE FOR INDIAN INFANTS DASII) 2.The children whose parents are willing to participate their child in the study and ready to sign the consent form.

排除标准

  • Children K/C/O Genetic & Chromosomal Abnormalities
  • Inborn Errors of Metabolism
  • All Diagnosed cases of congenital anomalies, protein energy malnutrition, rickets,.

结局指标

主要结局

Improvements in attainment of age-appropriate developmental milestones after intervention which were delayed during the initial assessment will be re- assessed using DASII ( Developmental Assessment Scale For Indian Infants)

时间窗: 0/90 DAY

次要结局

  • General improvement in the quality of children with developmental delays is assessed during the course of intervention between & after the completion of the intervention using CDC Grading.(1/10/45/56/90 day)

研究者

发起方
DR ANJITH C BABU
申办方类型
Other [self]

研究点 (1)

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