None listed
Conditions
Interventions
Intervention1: Cold Relief Roll-on: Mode of usage: Gently apply roll on over chest neck, back and soles of feet area. Frequency: Use as needed or as directed by paediatrician Route of administration:
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.The subject is of either sex, aged 0-36 months at the time of the parental consent and had birth weight as more or equal to 2.8 Kg. 2.Subject has acute cold symptoms with signs and symptoms as listed below but not limited to Nasal congestion/blockage, Itchy nose, Sneezing, Runny nose. 3.Exclusively breast-fed babies up to the age of 6 months. 4.Overall healthy baby as per Paediatrician. 5.Subject’s parent/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent and agree to complete study activities and come for regular follow-up with a subject. 6.Medically stable babies without any requirement of drugs interventions, procedures, nutraceutical or other health supplement. 7.The subject’s parent/legal guardian for their child is preferably willing to abide by and comply with the study protocol. 8.The subject should not participate in any other clinical study during participation in the current study. 9.Subject has normal vital parameters. Respiratory rate in resting condition is 24-40 breaths/minutes Forehead temperature less than 100°F
Exclusion criteria
Exclusion criteria: 1.Subjects who are sick, have muscular trauma, chronic lung infection, cystic fibrosis, skin infections, congenital anomalies, neuromuscular disorders or any other medical conditions that may be deemed unsuitable by the investigator for the subject’s participation in the study. 2. Subject has history or present condition of an allergic response to any other similar products, or ingredients as in the test product. 3. Concomitant use of medications known to adversely interact with the test product or its related ingredients. 4.Subject is requiring incubators/ventilators or C-PAP. 5.Subject has participated in a similar clinical investigation in the past four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort -1 (Cold relief roll on) 1 relief in acute cold, clinical symptoms of nasal congestion, sneezing, nasal itching, and rhinorrhoea by a paediatrician-trained evaluator or paediatrician / study physician, using Total Nasal Symptom Score (TNSS) – a 4-point scale as below or any other similar scale 2 improvement in acute cold clinical symptoms using Visual Analog Score 3 Subjective Product Perception Assessment using 5 point scoring scale 4 Quick absorption of Baby Roll-on by tissue absorbent cohort -2 (Baby massage oil) 1 Change in anthropometrical parameters 2. Change in lab parameters 3. Change in cardiovascular and immunological parameters 4.changes in physical growth, sleep patterns, calorie intake, stress behaviours, body activity 6. change in skin hydration and transepidermal water loss using instrumental assessment 7 change in visual analog scale and subjective questionnaireTimepoint: Cohort 1 cold relief roll on 1 Before and after usage of the test product on day 01, day 02 and day 07 as per the protocol. Cohort 2 Baby Massage oil 1 Before and after usage of the test product on day 01 day 14, day 30 and day 60 as per protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed