None listed
Conditions
Interventions
Intervention1: Pediatric Formula: Dietary supplement for Infantile Colic, 1.2 ml to be given orally SOS
Control Intervention1: Placebo: Flavored water 1.2 ml to be given orally SOS
Sponsors
Vedic Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Participants and caregivers will be included in the study if they fulfil ALL of the below mentioned criteria â?? 1. Otherwise healthy infants as determined by the investigator; aged between >=3 â?? 2. Infantile colic as per Rome IV criteria: a. Infants less than five months of age when symptoms of infantile colic start and stop. b. Recurrent and prolonged periods of infant crying, fussing or irritability reported by caregivers that occur without any obvious cause and cannot be prevented or resolved by caregivers c. No evidence of infant failure to thrive, fever or illness. d. Parental reporting of crying more than 3 hours/day for at least 3 days/week (Supplemented with 24 hrs diary at randomization). 3. Birth weight 2500 â?? 4000 gm. Caregivers Inclusion Criteria 1. Parents/guardians are literate enough to understand the essence of the study, are informed about the purpose of the study, and understand their rights. 2. Those willing to complete the modified Barrâ??s baby daily crying diary. 3. Mothers willing to abstain from any change in feeding patterns, infantâ??s diet, living conditions (Specifically infantâ??s surrounding), and any other factor that would confound the study outcomes. 4. The caregiver is able to give written informed consent and shows willingness to participate in the study and comply with its procedures.
Exclusion criteria
Exclusion criteria: Participants and caregivers will be excluded from the study if they fulfil ANY of the following criteria: 1. Infants 16 weeks of age at the screening visit. 2. Birth weight 4000 g 3. Mothers/caretakers and/or infants having clinical evidence of significant acute or chronic existing illness [cardiovascular, gastrointestinal, immunological, etc] or a condition, which in the investigatorâ??s judgment contraindicates involvement in the study. 4. Breastfeeding mothers and/or infants taking a medication, dietary supplement or food product that the investigator believes would interfere with the objectives of the study, pose a safety risk or might confound study result interpretation. 5. Mothers and/or infants who are receiving treatment involving experimental drugs. 6. Infants with a disorder that may affect the bowel or urinary tract in any relevant way (such as scrotal and inguinal swelling, distended abdomen, etc). 7. Mothers who consume alcohol, smoke, and use any other form of tobacco. 8. Breastfeeding mothers with a history of antibiotic use in the last 15 days. 9. Infants receiving formula for special medical purposes. 10. Participation in any other clinical interventional study 11. Inability of the caregiver to complete the diary, survey scales and visit the clinical site as per appointments. 12. Mothers having twins or triplets. 13. Those who in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Colic Calm administration on daily crying time in infants at the end of 1st week (Day 7) and 2nd week of treatment (day 14) from baseline (day 0) as assessed by modified Barrâ??s diary.Timepoint: Day 0 vs Day 7 vs Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of Colic Calm administration on daily crying time in infants in comparison to placebo, as assessed by modified Barrâ??s diary.Timepoint: Day 0 vs Day 14;2. To evaluate the effect of Colic Calm administration on the percentage of responders and non-responders in comparison to placebo, as evaluated by infants reporting a â?¥50% reduction in daily average crying time.Timepoint: Day 0 vs Day 14;3. To evaluate the effect of Colic Calm administration on improvement in sleeping pattern of infants from baseline (Day 0), as evaluated by an average number of hours asleep reported in modified Barrs diaryTimepoint: Day 0 vs Day 14;4. To evaluate the effect of Colic Calm administration on improvement in the frequency and severity of gastrointestinal symptoms (average of 7â??days) from baseline (Day 0), as assessed by the â??Infant Gastrointestinal Symptom Questionnaireâ??.Timepoint: Day 0 vs Day 14;5. To evaluate the effect of Colic Calm administration on global evaluation of tolerability of the IP, related to gastric symptoms in comparison to placebo, as reported by the infantâ??s caretaker.Timepoint: Day 0 vs Day 14;6. To evaluate the effect of Colic Calm administration on percentage population with relapse of symptoms indicative of colic post IP discontinuationTimepoint: Day 14 vs Day 21 | — |
Countries
India
Contacts
Public ContactDr Shalini Srivastava
Vedic Lifesciences Private Limited
Outcome results
None listed