NovoBliss Research Pvt Ltd
Gandhinagar, Gujarat, 382421, India
NCT Number: NCT05775237
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.
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Notify Me2 year–12 year
All sexes
Interventional
Not applicable
Gandhinagar, Gujarat, 382421, India
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Chew gummies thoroughly and completely before swallowing.
Other names: curcumin
Chew gummies thoroughly and completely before swallowing.
Other names: Vitamin C
Chew gummies thoroughly and completely before swallowing.
Other names: Multivitamin
Time frame: Day 01 before test product usage to 30 Day after Test product usage
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
To evaluate the Efficacy of Test Product by using subject perception questionnaires regarding Health
Time frame: 30 Day after usage of Test product
To evaluate the Organoleptic properties of Test Product by using subject perception questionnaires regarding Test Product
NovoBliss Research Pvt Ltd
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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