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A Study To Evaluate The Effect Of Swarnaprashana Given Along With Routine Vaccination In Newborns Or Infants 0 to 2 Months

An Open Label Randomised Control Trial To Evaluate The Impact Of Swarnaprashna When Co Administered With Conventional Immunization In Neonates or Infants Of 0 to 2 Months - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109847
Enrollment
80
Registered
2026-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Dr Vaishnavi Dasu Nalla
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Full term neonates or infants aged 0-2 months 2 Neonates delivered via Normal vaginal delivery or caesarean section (LSCS) 3 Full term neonates or infants of either sex 4 Informed consent obtained through parents 5 Birth weight of neonates more than 2kgs

Exclusion criteria

Exclusion criteria: 1 Preterm Infants 2 History of birth asphyxia, neonates with pathological jaundice 3 Congenital anomalies and genetic defects 4 All systemic disorders 5 Syndromic babies 6 Infants with NICU admission

Design outcomes

Primary

MeasureTime frame
To evaluate the health status of neonates through infant health related quality of life instruments after co administration of Swarnaprashna with conventional immunization in infants of 0 to 2 monthsTimepoint: 0th day, 2nd week, 4th week, 6th week—

Secondary

MeasureTime frame
1 To evaluate the impact of Swarnaprashna when co administered with conventional immunization in infants of 0 to 2 months through IL-1 expression 2 To evaluate ADR as per AYUSH Suraksha reporting format to pharmacovigilance department of institution during drug administration.Timepoint: 6th week—

Countries

India

Contacts

Public ContactDr Sahana Shankari

SDM College of Ayurveda, Hospital and Research Centre, Kuthpady, Udupi, Karnataka

sahanashankari29@gmail.com9741896978

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026