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Completed

NCT Number: 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

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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Key information

Conditions

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovoBliss Research Pvt Ltd

Gandhinagar, Gujarat, 382421, India

About this 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curcumin Gummies

Dietary Supplement

Chew gummies thoroughly and completely before swallowing.

Other names: curcumin

Vitamin C Gummies

Dietary Supplement

Chew gummies thoroughly and completely before swallowing.

Other names: Vitamin C

Multivitamin Gummies

Dietary Supplement

Chew gummies thoroughly and completely before swallowing.

Other names: Multivitamin

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

NovoBliss Research Pvt Ltd

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2023
Registry last updated
Nov 9, 2023

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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