Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Children
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of clinical study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Age: 02 to 12 years old (both inclusive) at the time of parental consent.
2. Overall good health of the child subject is determined by medical examination and history evaluated by the Investigator.
3. 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.
4. The subject's mother/legal guardian for their child is preferably willing to abide by and comply with the study protocol.
5. The subject should not participate in any other clinical study during participation in the current study
6. Subject are agreed to maintain current level of activity through the study.

Exclusion Criteria:

1. Subjects with known history of allergies or specific allergic reactions upon using curcumin, vitamins, zinc, pantothenic acid.
2. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
3. Subjects, who in the opinion of the Investigator or the Expert physician are not eligible for enrolment in the study.
4. Subject who are unwilling to provide consent.

Primary outcomes:
measure: Assessment of Safety
timeFrame: Day 01 before test product usage to 30 Day after Test product usage
measure: Assessment of Efficacy
timeFrame: Day 01 before test product usage to 30 Day after Test product usage
measure: Assessment of Organoleptic properties
timeFrame: 30 Day after usage of Test product
Secondary outcomes:
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: NovoBliss Research Pvt Ltd
state: Gujarat
Study officials:
affiliation: Principal Investigator
name: Dr. Chitra Prajapati, MBBS
role: PRINCIPAL_INVESTIGATOR
References: