Year: 2026 | Month: July | Volume: 13 | Issue: 7 | Pages: 1-9
DOI: https://doi.org/10.52403/ijrr.20260701
Safety and Efficacy Study of EqualsTwo® Cold Relief Roll-on in Infants and Toddlers
Dr. Dhruv Zaveri1, Kinjal Barot1, Jaimin Vaishnav1, Dr. Nirav Patel2, Dr. Nayan Patel3, Dr. Maheshwari Patel3, Dr. Sunil S. Iyer4, M.E. Kannan5
1Biopharmaceutics and Clinical Development, Zydus Lifesciences Limited, Pharmaceutical Technology Centre (PTC), Sarkhej Bavla N.H. No.8A, Moraiya, Tal: Sanand, Dist.: Ahmedabad 382 210, Gujarat, India
2Ashirwad Children Hospital, Vandemataram - Gota, Ahmedabad – 382470, Gujarat, India
3Novobliss Research, Gota, Ahmedabad – 382481, 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: Dr. Dhruv Zaveri
ABSTRACT
Background: Acute upper respiratory tract infections are highly prevalent in infants and toddlers, causing nasal congestion, sleep disruption, and caregiver distress. Pharmacologic cold remedies are not recommended in this age group, creating a need for safe, natural alternatives.
Objectives: To assess the safety, tolerability, and efficacy of the EqualsTwo® Cold Relief Roll-on (investigation product) in reducing cold symptoms and improving comfort in infants and toddlers aged 0–36 months.
Methods: This prospective, open-label study enrolled 37 infants and toddlers with acute cold symptoms. Participants received topical application of the investigation product for 7 days. Efficacy and tolerability endpoints included changes in Total Nasal Symptom Score (TNSS), time to onset and overall relief of symptoms through Visual Analog Scale (VAS), caregiver-reported outcomes, dermatological assessment, and absorption profile. Safety was monitored through adverse event reporting.
Results: All enrolled pediatric patients completed the study. TNSS scores declined rapidly and significantly (p<0.0001), reaching complete symptom resolution within 3 hours and remained low through Day 7. Overall relief occurred in >80% within half an hour and 100% within 3 hours. Caregivers reported improvements in comfort, sleep quality, and ease of breathing, with 100% overall satisfaction. The investigation product was rapidly absorbed, non-greasy, and well tolerated, with no adverse events reported.
Conclusions: The investigation product is safe, well tolerated, and effective in providing rapid, sustained relief of acute cold symptoms in infants and toddlers, offering a natural and practical solution for management of cold symptoms in pediatrics.
Keywords: Common Cold, Eucalyptus oil, Mentha piperita, Nasal congestion, Rosmarinus officinalis, Upper respiratory tract infection
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