Treatment of ABDOMINAL COLIC PAIN using Gastica Drops in childre

Phase 4

Recruitment & Eligibility

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

1.Illiterate mothers

2.Premature birth or low birth weight ( <2500 g)

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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