survey to examine the acceptability of the product Vitazyme Drops in young child to manage severe pain in the abdomen caused by wind or obstruction in the intestine characterized by high pitch crying, restlessness

Evaluation of efficacy and safety of a proprietary digestive and carminative paediatric oral drop formulation in the management of indigestion and flatulence (colic) in infants and young children

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/04/018561

Enrollment

200

Registered

2019-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K598- Other specified functional intestinal disorders

Interventions

Intervention1: Vitazyme Drops: 1. Diastase IP (1:2000) 20 mg (Fungal

derived from Aspergillus oryzae) 2. Cinnamon oil BP 200 mcg 3. Cardamom oil IP 400 mcg 4. Caraway oil IP 400 mcg Colourant : Caramel IP Dosage-0.5 ml, Three Times a Day for 7 days Control In

Eligibility

Inclusion criteria

Inclusion criteria: i. Infants & young children of both sexes aged between 1 month and 2 years. ii. Suffering from symptoms suggestive of indigestion, flatulence, chronic constipation, persistent loose stools or poor appetite in general (as perceived by the parent) with or without colicky abdominal pain. iii. Parent or legally acceptable representative willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: i. Preterm infants (born before 37 completed weeks of gestation). ii. Low-birth weight infants (weighing less than 2500 gms at birth). iii. Concomitant serious medical problems including failure to thrive. iv. Known lactose intolerance or intolerance to infant feeding formulae (baby food). v. Suffering from diarrhoea or loose stools which could be of infectious origin. vi. Suffering from any other symptoms suggestive of an ongoing infection. vii. Child receiving non-permitted concomitant medication. viii. Any other condition which in the opinion of the investigator is not conducive towards inclusion of the subject in the study.

Design outcomes

Primary

Measure	Time frame
i. Improved digestion & flatulence â?? as judged by the absence of excessive regurgitation, hiccups, belching / eructation, abdominal distension, excessive flatulence, nausea, vomiting. ii. Increase in colic-free periods â?? as judged by a reduction in mean daily crying time, particularly during the night.Timepoint: 3 visits in a complete study	—

Secondary

Measure	Time frame
safetyTimepoint: In case of Adverse Event unscheduled visit at any time in the study duration	—

Countries

India

Contacts

Public ContactDr Sukumar Ghosh

East India Pharmaceutical Works Limited

research1@eastindiapharma.org9831394071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026