Year: 2026 | Month: July | Volume: 13 | Issue: 7 | Pages: 276-286
DOI: https://doi.org/10.52403/ijrr.20260731
Evaluation of the Efficacy and Safety of EqualsTwo® Baby Massage Oil in Promoting Growth, Skin Health, and Neurobehavioral Outcomes in Healthy Infants: A 60-Day Clinical Study
Kinjal Barot1, Dhruv Zaveri1, Jaimin Vaishnav1, Nirav Patel2, Nayan Patel3, Sunil S. Iyer4, M. E. Kannan5
1Biopharmaceutics and Clinical Development, Pharmaceutical Technology Centre (PTC), Zydus Lifesciences Limited, Sarkhej Bavla N.H. No.8A, Moraiya, Tal: Sanand, Dist.: Ahmedabad 382 210, Gujarat, India,
2Ashirwad Children Hospital, Near Praveen Petrol Pump, Rajoda, Bavla, Gujarat – 382220, India
3Novobliss Research, Silver Radiance-4, 313, Chanakyapuri, Ahmedabad – 380060, Gujarat, India
4Head, Biopharmaceutics and Clinical Development, Zydus Lifesciences Limited, Sarkhej Bavla N.H. No.8A, Moraiya, Tal: Sanand, Dist.: Ahmedabad 382210, Gujarat, India
5Head, Pharmaceutical Technology Centre (PTC), Zydus Lifesciences Limited, Sarkhej Bavla N.H. No.8A, Moraiya, Tal: Sanand, Dist.: Ahmedabad 382210, Gujarat, India.
Corresponding Author: Kinjal Barot
ABSTRACT
Objectives: Infancy is a critical period marked by rapid physical, neurological, and immune development. Interventions that support growth and well-being during this window are essential. Massage therapy has emerged as a safe, effective, non-pharmacological approach for preterm and low-birth-weight infants; however, limited data exist on its efficacy in healthy infants and toddlers under real-world conditions. To evaluate the efficacy and safety of EqualsTwo® Baby Massage Oil (Investigation product) in improving growth parameters, sleep, behavior, skin hydration, and mother/caregiver satisfaction in healthy infants and toddlers (≤3 years) over a 60-day period.
Methods: This prospective, randomised, controlled, open-label study enrolled 64 healthy infants and toddlers aged ≤3 years (n=32; Test group n=32; Control group). 57 participants completed the study (30 in the test group; 27 in the control group). Anthropometric measurements, sleep patterns, skin hydration, and behavioural cues were assessed at baseline, Day 14, Day 30, and Day 60, while blood flow dynamics and serum biochemical markers were evaluated at baseline and Day 60. Statistical analysis was conducted using t-tests or chi-square tests as appropriate.
Results: The test group showed statistically significant, greater improvements across all primary and secondary outcomes, including a 3.1-fold increase in anthropometric growth, 15.8-fold improvement in sleep duration, 212% rise in skin hydration, 92.9% increase in blood volume flow, and marked behavioral improvements. No adverse events were reported, and mother/caregiver satisfaction was uniformly high.
Conclusion: Daily massage with investigation product (EqualsTwo® Baby Massage Oil) is a safe and effective intervention to enhance overall infant growth and well-being.
Keywords: Growth and development, Infant massage, Natural baby oil, Skin hydration, Sleep quality.
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