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Clinical Trials/CTRI/2025/02/079975
CTRI/2025/02/079975
Not yet recruiting
Phase 2/3

Clinical study to evaluate the efficacy of samvardhana ghrita through various routes of administration as an early intervention in the management of developmental delay

Sri Dharmasthala Manjunatheshwara College Of Ayurveda And HospitalHassan1 site in 1 country20 target enrollmentStarted: February 18, 2025Last updated:

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

Sponsor
Sri Dharmasthala Manjunatheshwara College Of Ayurveda And HospitalHassan
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Pooja HP

SDM college of Ayurveda and hospital, Hassan

Study Sites (1)

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