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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Assessment of Safety
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
This Study is Open-label
Eligibility Criteria
- Ages
- 2 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 02 to 12 years old (both inclusive) at the time of parental consent.
- •Overall good health of the child subject is determined by medical examination and history evaluated by the Investigator.
- •Subject's mother/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent form and agree to complete study activities and come for regular follow-up with a subject.
- •The subject's mother/legal guardian for their child is preferably willing to abide by and comply with the study protocol.
- •The subject should not participate in any other clinical study during participation in the current study
- •Subject are agreed to maintain current level of activity through the study.
Exclusion Criteria
- •Subjects with known history of allergies or specific allergic reactions upon using curcumin, vitamins, zinc, pantothenic acid.
- •Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
- •Subjects, who in the opinion of the Investigator or the Expert physician are not eligible for enrolment in the study.
- •Subject who are unwilling to provide consent.
Arms & Interventions
Curcumin Gummies
Curcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin.
Intervention: Curcumin Gummies (Dietary Supplement)
Vitamin C Gummies
Vitamin C Gummies contain Vitamin C and Zinc
Intervention: Vitamin C Gummies (Dietary Supplement)
Multivitamin Gummies
Multivitamin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, sodium, Vitamin C, Vitamin E, pantothenic acid, Zinc, iodine, Vitamin A, Magnesium, Folate, Vitamin D, Vitamin 12
Intervention: Multivitamin Gummies (Dietary Supplement)
Outcomes
Primary Outcomes
Assessment of Safety
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
Assessment of Efficacy
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
Assessment of Organoleptic properties
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Chitra Prajapati
Principal Investigator
NeighbourCare Clinics