CTRI/2022/12/048635Not yet recruitingPhase 2/3
Randomized controlled clinical trial to compare erandmool-amlak churna with neosporin powder in umbilical cord care.
Tilak Ayurved Mahavidyalaya ,Pune1 site in 1 country60 target enrollmentStarted: February 1, 2023Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Fall of umbilical cord without any inflammation and discharge.
Study Overview
Brief Summary
Neonatal sepsis is the most important cause of morbidity and mortality.Though modern medicine is progressive but drugs used in umbilical sepsis in neonates has too much side effects so to establish the importance of Ayurvedic concepts and remedies related to Nabhinal paricharya,this study is selected.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •All Full term neonates Willing of parents.
Exclusion Criteria
- •Neonates having pain or swelling or any inflammation sign at umbilical region.
- •Neonates admitted in NICU.
- •Non willing parents.
- •Neonates having congenital defects or who have been resuscitated.
Outcomes
Primary Outcomes
Fall of umbilical cord without any inflammation and discharge.
Time Frame: baseline,3days,5days,7days,15days.
Secondary Outcomes
- Serous or any other discharge , inflammation after falling of umbilical cord.(15 days)
Investigators
Study Sites (1)
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