Ayurveda Management Of Global Developmental Delay

Phase 2/3

Not yet recruiting

Conditions: Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: VATAVYADHIH,

Registration Number: CTRI/2023/06/053628

Lead Sponsor: DR ANJITH C BABU

Brief Summary: 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 *Rasayana*3. 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.*

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

Children K/C/O Genetic & Chromosomal Abnormalities 2.
Inborn Errors of Metabolism 3.
All Diagnosed cases of congenital anomalies, protein energy malnutrition, rickets,.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	0/90 DAY

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
🇮🇳
Hassan, KARNATAKA, India
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
🇮🇳Hassan, KARNATAKA, India
DR ANJITH C BABU
Principal investigator
7996602710
anjith.babu2@gmail.com