Health Condition 1: R681- Nonspecific symptoms peculiar to infancy
Conditions
Interventions
None listed
Sponsors
Mother Sparsh Baby Care Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects between the age group of 1st week to 1 year (of both genders). 2. Recurrent and prolonged periods of crying, fussing, or irritability reported by caregivers associated with colic discomfort as per parental judgement. 3. Subjects with specific FLACC score. 4. Subjects with specific IGSQ score. 5. Parents or guardians willing to let their new born or infants participate in this trial and sign a written consent form before the trial begins.
Exclusion criteria
Exclusion criteria: 1. Subjects above 1 year of age. 2. Subjects with chronic colic discomfort, abdominal colic necessitating emergency intervention, excretory system disorders, known congenital or metabolic anomalies or any chronic illness, allergies necessitating medications which can impact the study or subject judged by the investigator to be inappropriate for this trial. 3. Subjects receiving formula for specific medical purposes. 4. Subjects not willing to stop the use of other tummy oil or any medication for this indication during study period. 5. Subjects whose parents or guardians hesitant to sign the informed consent form or abiding by the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the discomfort intensity, indigestion, constipation/loose stools, episodes of colic in a day and crying duration.Timepoint: Baseline, 30 minutes, 1 hour, 3 hours, 24 hours, Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the discomfort irritation/reactions as per investigator s assessment of parent s observations.Timepoint: Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3;Mean change in episodes of sleep interruption in 24 hrs as per investigator s assessment of parent s observations.Timepoint: Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3;Mean change in duration for expelling gas/stool as per investigator s assessment of parent s observations.Timepoint: Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3;Mean change in quality of life as per investigator s assessment of parent s observations.Timepoint: Baseline, 30 minutes, 1 hours, 3 hours, 24 hours, Day 3 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed