NCT05775237

An Investigator-initiated Trial to Assess the Effectiveness of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children

An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

Summary

An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of Three Different Gummies (Curcumin Gummies, Vitamin C Gummies, and Vitamin B Complex Gummies) in Healthy Children. A sufficient number (maximum of 48, (16 children/arm)) of children subjects will be recruited to ensure a total of 45 subjects (15 children /arm) complete the study.

Detailed description

Qualifying siblings within the same household are permitted in the study. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written parental informed consent and from the subjects and subjects' legal parent/legal guardian. The subject's parents will be instructed to visit the facility as per the below visits: * Visit 01 (Day 01): Screening, Enrolment Visit * Visit 02 (Day 30): Evaluations, End of Study Visit Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by the recruiting department prior to the enrolment visit. Assessment of safety, efficacy and organoleptic properties will be done on Day 01 as a baseline before test product usage to Day 30 after test product usage. Reduction in frequency of getting the sickness. Consumer feedback-subjective questionnaires - Health Questionnaire Product Perception Questionnaire - Organoleptic parameters.

Conditions

• Healthy Children

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Curcumin Gummies	Chew gummies thoroughly and completely before swallowing.
DIETARY_SUPPLEMENT	Vitamin C Gummies	Chew gummies thoroughly and completely before swallowing.
DIETARY_SUPPLEMENT	Multivitamin Gummies	Chew gummies thoroughly and completely before swallowing.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-06-01
• Completion: 2023-07-06
• First posted: 2023-03-20
• Last updated: 2023-11-09

Locations

1 site across 1 country: India