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

November 7, 2023 updated by: Dr Chitra Prajapati, NovoBliss Research Pvt Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Gandhinagar, Gujarat, India, 382421
        • NovoBliss Research Pvt Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curcumin Gummies
Curcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin.
Dietary supplement: Curcumin Gummies
Chew gummies thoroughly and completely before swallowing.
Other Names:
  • curcumin
Experimental: Vitamin C Gummies
Vitamin C Gummies contain Vitamin C and Zinc
Dietary supplement: Vitamin C Gummies
Chew gummies thoroughly and completely before swallowing.
Other Names:
  • Vitamin C
Experimental: 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
Dietary supplement: Multivitamin Gummies
Chew gummies thoroughly and completely before swallowing.
Other Names:
  • Multivitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 01 before test product usage to 30 Day after Test product usage
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
Day 01 before test product usage to 30 Day after Test product usage
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
30 Day after usage of Test product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovoBliss Research Pvt Ltd

Investigators

  • Principal Investigator: Dr. Chitra Prajapati, MBBS, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 6, 2023

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NB230001-NCP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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