Clinical study to evaluate the efficacy of samvardhana ghrita through various routes of administration as an early intervention in the management of developmental delay
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Sri Dharmasthala Manjunatheshwara College Of Ayurveda And HospitalHassan
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Mental age
Overview
Brief Summary
Developmental delay manifests as failure to reach age appropriate milestones in multiple domains
Persistence of primitive reflexes beyond expected regression ages indicates potential delay. Early
screening and intervention have proven effective, with Ayurvedic methods offering promising
prospects. Masthishka abhighata, a possible contributor to developmental delay is addressed in
Ayurvedic texts. Certain factors influencing on growth and development of the child can be assessed to
the earliest i.e., from the very next moment after conception.The term samvardhana is found in kashyapa Samhita Lehanadhyayam while explaining Samvardhana
ghrita , different lehya formulations for developmental disorders like Mukatha, Panguta, Ashruthi,
etc.Samvardhana is a special characteristic feature of children, which distinguishes them from an adult.
Not all faculties develop at a time in the infant. The child acquires different skills and talents at different
periods of growth and development. Thus, failure to achieve different milestones could grossly be
termed as samvardhana vikaras which at earliest to be intervened and proper care to be taken. Thus
using of certain ayurvedic treatment like pratimarsha nasya, matra basti modalities will be useful in
achieving and attaining milestone domains at the earliest
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 6.00 Month(s) to 24.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •Children aged between 6 months and 24 months, regardless of gender, who meet the diagnostic criteria Children whose parents are willing to enroll them in the study and are prepared to sign the consent form.
Exclusion Criteria
- •Children who are K/C/O Genetic & Chromosomal Abnormalities Children who are diagnosed with cases of congenital anomalies protein-energy malnutrition rickets and uncontrolled seizures.
Outcomes
Primary Outcomes
Mental age
Time Frame: Day 0 | Day 90
The following criteria will be assessed
Time Frame: Day 0 | Day 90
Motor age
Time Frame: Day 0 | Day 90
And milestones attained appropriate for age
Time Frame: Day 0 | Day 90
Secondary Outcomes
- The parameters assessed for the child(Motor age)
Investigators
Dr Pooja HP
SDM college of Ayurveda and hospital, Hassan