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Study on Low Birth Weight neonates for improving weight gain and sleep quality

Efficacy of Bala ashwagandhadi Taila Abhyanga (Massage) on improving weight gain and sleep quality in Low-Birth-Weight neonates (Alpabhara Shishu)- an open-labelled Randomized Comparative Clinical Trial. - Nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083570
Enrollment
100
Registered
2025-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: P071- Other low birth weight newborn

Interventions

None listed

Sponsors

All India Institute of Ayurveda, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically stable Low Birth Weight neonates (1.5 kg to 2.499 kg) irrespective of sex and ethnicity. 2. Born via NVD and LSCS with an APGAR score of more than 7 in the first minute of birth. 3. Neonates with a history of LBW, up to 6 months of age (if weight is not appropriate to age at the time of assessment) visiting the hospital for routine checkups and vaccination. 4. Gestational age at birth should be above 28 weeks

Exclusion criteria

Exclusion criteria: 1. Very Low Birth Weight Neonates 2. Extremely pre-term neonate 3. Skin Diseases (Atopic Dermatitis, napkin Rash, contact dermatitis, etc.) 4. Birth Injuries 5. Pathological Neonatal Jaundice 6. Major congenital anomaly, newborn in NICU, 7. Congenital Infections, CNS Dysfunction e.g. Intraventricular Haemorrhage and History of Seizures 8. TPN, Mechanical Ventilation, and supplementary oxygen therapy 9. Neonates developing fever, signs of sepsis, respiratory distress, necrotizing enterocolitis, seizures, neurological dysfunction, or any other illnesses. 10. Neonates sensitive to massage oil test dose

Design outcomes

Primary

MeasureTime frame
To achieve age-appropriate improvement in weight gain (velocity) in LBW neonates.Timepoint: At Birth or at time of enrollment, Day 21 and Day 42

Secondary

MeasureTime frame
Age-appropriate increase in length, head circumference, and skinfold thickness. Improvement in quality of sleep Changes in the score of the NBAS ScaleTimepoint: Day1, Day21, Day 42 NBAS Day1 and Day 42

Countries

India

Contacts

Public ContactDr Rajagopala S

All India Institute of Ayurveda

ayuarun@gmail.com8506821947

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026