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

Healthy Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05775237
• Other study ID #: NB230001-NCP
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 6, 2023

Study information

• Verified date: November 2023
• Source: NovoBliss Research Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 6, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Children

Intervention

Dietary Supplement:
• Curcumin Gummies
Chew gummies thoroughly and completely before swallowing.
• Vitamin C Gummies
Chew gummies thoroughly and completely before swallowing.
• Multivitamin Gummies
Chew gummies thoroughly and completely before swallowing.

Locations

Country	Name	City	State
India	NovoBliss Research Pvt Ltd	Gandhinagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
NovoBliss Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Safety	To evaluate the Safety of Test Product by using subject perception questionnaires regarding Health	Day 01 before test product usage to 30 Day after Test product usage
Primary	Assessment of Efficacy	To evaluate the Efficacy of Test Product by using subject perception questionnaires regarding Health	Day 01 before test product usage to 30 Day after Test product usage
Primary	Assessment of Organoleptic properties	To evaluate the Organoleptic properties of Test Product by using subject perception questionnaires regarding Test Product	30 Day after usage of Test product