Health Condition 1: null- Infantile Colic
Conditions
Interventions
Intervention1: Gastica: Gastica Drops Simethicone 40mg Fennel Oil 0.0007 ml and Dill Oil 0.005 ml per ml of oral liquid Dose
Control Intervention1: Placebo: An inert substance without any pharmacolo
Sponsors
MANKIND PHARMA LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Infants from 0 to 2 years of age. 2. Paroxysmal attacks of irritability and/or restlessness. 3. Crying is observed for more than 3 hours a day, three days a week for one week. 4. Infant of relatively sound health 5. Breastfed, Formula fed and Dairy milk fed infant 6. Crying sound is more intense than normal, like a high pitched scream 7. Crying even after feeding or rocking 8. Fist clenching while crying 9. Bending of arms and legs towards belly 10. Tightening stomach muscles 11. Passing gas while crying 12. Bloated tummy 13. Face turning red or flushed while crying
Exclusion criteria
Exclusion criteria: 1. Illiterate mothers 2. Premature birth or low birth weight ( 3. Failure to thrive 4. Gastrointestinal disorders 5. Currently infectious, allergic or metabolic disease 6. Children receiving any type of treatment (drug, herbal products or chiropractic manipulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Purpose is to study Safety and Efficacy of Gastica Drops in the supportive care of colic in infants from 0 to 2 years of age. The protocol is designed to evaluate the intervention where primary intent is to maximize comfort, minimize side effects or mitigate against a decline in the subjectâ??s health or function.Timepoint: Volunteers will be screened at Visit 1 and eligible subjects will, be randomized to either Gastrica Drops [Infants (below 6 months): 5-10 drops 4 times daily; Infants (6-12 months): 10-20 drops 4 times daily; Infants (12-24 months): 20-25 drops 4 times daily] or a placebo control of similar appearance. Visit 2 (final) will be scheduled at 1 week interval. Safety tests will be performed at the visit 1 and end of visit 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events throughout studyTimepoint: Subjectâ??s Parents/Guardians will enter adverse events and daily use of study medication in a subject diary till Visit 2. Adverse events will be recorded at the visit 1 and end of visit 2.;Secondary efficacy endpoints for this study are number of milk regurgitation episodes, vomiting, diarrhea, constipation and drowsiness. Number of patients along with the percentages will be reported for the above mentioned categories by treatmentTimepoint: Visit 1 and visit 2 | — |
Countries
India
Contacts
Public ContactDr Manish Narang
Guru Teg Bahadur Hospital
Outcome results
None listed