Effects of Groviva on growing children.

A Post marketing real world study to evaluate the effect of GROVIVA on growth, development, and health of children of age 2-12 years. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/02/063252

Enrollment

775

Registered

2024-02-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

None listed

Interventions

Intervention1: Groviva: GROVIVA® is a scientifically formulated nutritional supplement to support growth & development in children Manufactured by Signutra. GROVIVA® contains Certi 5 Signature nutrie

Eligibility

Inclusion criteria

Inclusion criteria: o Male or female aged between 2 to 12 years. o Subjects or their representatives must sign with date an informed consent prior to any evaluation and participation in the trial. o Healthy child with BMI below 15th percentile

Exclusion criteria

Exclusion criteria: o Child suffering from diarrhea, serious medical condition, hormonal disorder o Participation in another trial with another investigational product.

Design outcomes

Primary

Measure	Time frame
Change over 6 months of nutritional intervention in o Weight o Height o BMI o Less sick days (constipation incidences). Timepoint: Change over 6 months of nutritional intervention in o Weight o Height o BMI o Less sick days (constipation incidences).	—

Secondary

Measure	Time frame
Gut health (gastric irritability, indigestion, gastric pain, nausea, vomiting, flatulence, constipation), Adverse events (if any) assessment of hunger and general well-being.Timepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Nidhi Gupta

Mediception Science Pvt Ltd.

nidhi@mediception.com09810335651

Outcome results