A Study to Evaluate the Efficacy of Siddharthakadi Ghrita as Lehana on Arogya in Infants W.S.R. to Growth and Development
Phase 2
- Registration Number
- CTRI/2023/07/054735
- Lead Sponsor
- Dr.PRAVEENA MAVILA VEED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1) Neonates irrespective of their gender, religion will be included.
2) Healthy term neonates who are appropriate for gestational age will be included.
3) Neonates who are exclusively on breast feeding will be included.
4) Neonates whose parents are willing to sign the written consent form will be included.
Exclusion Criteria
1) Infants whose age is above 1 month at the time of enrolment will be excluded.
2) Pre-term, Post-term, Small for gestational age and Large for gestational babies will be excluded.
3) Neonates who are on supplementary feeds or other modes of feeding other than breast feeding will be excluded.
4) Neonates with inborn errors of metabolism, chronic systemic illness and congenital anomalies will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of growth on infant will be done based on following anthropometric parameters: 1.Weight of the infant in grams. <br/ ><br>2.Crown-Heel length of infant in centimeter. <br/ ><br>3. Head Circumference in centimeter. <br/ ><br>4. Chest Circumference in centimeter. <br/ ><br>5. Left mid upper arm circumference in centimeterTimepoint: 0TH day of enrolment <br/ ><br>During intervention - 30thday , 60th day , 90th day <br/ ><br>During follow up - 120th day, 150th day
- Secondary Outcome Measures
Name Time Method Assessment of development on infant will be done based on Development Assessment Scale for Indian Infants ( DASII ) <br/ ><br> <br/ ><br>Timepoint: 0TH day of enrolment <br/ ><br>During intervention - 30thday , 60th day , 90th day <br/ ><br>During follow up - 120th day, 150th day