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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
48
Chew gummies thoroughly and completely before swallowing.
Chew gummies thoroughly and completely before swallowing.
Chew gummies thoroughly and completely before swallowing.
NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, India
Assessment of Safety
To evaluate the Safety of Test Product by using subject perception questionnaires regarding Health
Time frame: Day 01 before test product usage to 30 Day after Test product usage
Assessment of Efficacy
To evaluate the Efficacy of Test Product by using subject perception questionnaires regarding Health
Time frame: Day 01 before test product usage to 30 Day after Test product usage
Assessment of Organoleptic properties
To evaluate the Organoleptic properties of Test Product by using subject perception questionnaires regarding Test Product
Time frame: 30 Day after usage of Test product
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.