Clinical study on Nourishing Baby Massage oil in Newborn childre
- Registration Number
- CTRI/2022/11/047646
- Lead Sponsor
- Marico Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Full term (born after 37 weeks of gestation) and preterm (born prematurely prior to 37 weeks gestation), either normal or C-Section, neonates (till the age of 28 days) weighing 2500 grams at the time of recruitment or more will be included if they fulfill the following inclusion criteria:
1.Apgar score >7 at 1 and 5 minutes with no resuscitation required at birth.
2.Medically stable with no requirement of drugs, or any interventions/procedures other than Nutraceuitcal / health supplement.
3.Parents of the babies willing to sign an informed consent
1.Neonates not on breast feed
2.Sick babies and those babies who have congenital anomalies or neuromuscular disorders.
3.Babies with muscular trauma or skin infections.
4.Parents of the Babies not willing to come for follow-up when required
5.Babies participating in any other clinical trials.
6.Known hypersensitivity to any of the ingredients of study product
7.Other conditions, which in the opinion of the investigators, make subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in anthropometrical measurements from baseline to each follow visit and against control. <br/ ><br>2. Changes in Z score from baseline to each follow visit and against control <br/ ><br>Timepoint: Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90)
- Secondary Outcome Measures
Name Time Method 1.Changes in orientation state, effect on mood, activity status, cooperation for massage and fidgeting/nervous behavior of subjects prior to massage, during massage and post massage <br/ ><br>2.Changes in sleep pattern <br/ ><br>3.Changes in Softness / suppleness / smoothness of skin <br/ ><br>4.Changes in muscle and bone strength <br/ ><br>5.Time taken for major milestones <br/ ><br>6.Changes in food intake on <br/ ><br>7.Changes in episodes, severity and duration of illness (infections or allergies) <br/ ><br>8.Changes in skin condition. <br/ ><br>9. Overall change in growth and behavior by investigator and parents / legal guardian <br/ ><br>10.Assessment of adverse events and vitals <br/ ><br>11.Tolerability of oil massage as per the parents / legal guardian and investigator <br/ ><br>Timepoint: Screening/ Baseline visit (Day 0), Visit 1 (Day 15), Visit 2 (Day 30), Visit 3 (Day 45), Visit 4 (Day 60), Visit 5 (Day 75), Visit 6 (Day 90)