Healthy ChildrenNCT05775237
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
A study testing Curcumin Gummies, Vitamin C Gummies and Multivitamin Gummies in people with Healthy Children, run by NovoBliss Research Pvt Ltd at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- What is being tested?
- Curcumin Gummies, Vitamin C Gummies and Multivitamin Gummies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2023to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Children
- Being tested
- Curcumin Gummies, Vitamin C Gummies, Multivitamin Gummies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin GummiesDietary supplement
Also called curcumin
Chew gummies thoroughly and completely before swallowing.
Vitamin C GummiesDietary supplement
Also called Vitamin C
Chew gummies thoroughly and completely before swallowing.
Multivitamin GummiesDietary supplement
Also called Multivitamin
Chew gummies thoroughly and completely before swallowing.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin Gummies | Experimental | Curcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin. Receives: Dietary Supplement: Curcumin Gummies |
| Vitamin C Gummies | Experimental | Vitamin C Gummies contain Vitamin C and Zinc Receives: Dietary Supplement: Vitamin C Gummies |
| Multivitamin Gummies | Experimental | 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 Receives: Dietary Supplement: Multivitamin Gummies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Safety
To evaluate the Safety of Test Product by using subject perception questionnaires regarding Health
Measured: Day 01 before test product usage to 30 Day after Test product usage
Assessment of Efficacy
To evaluate the Efficacy of Test Product by using subject perception questionnaires regarding Health
Measured: Day 01 before test product usage to 30 Day after Test product usage
Assessment of Organoleptic properties
To evaluate the Organoleptic properties of Test Product by using subject perception questionnaires regarding Test Product
Measured: 30 Day after usage of Test product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of clinical study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Chitra Prajapati, NeighbourCare Clinics
- Investigators
- Dr. Chitra Prajapati, MBBS, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775237
- Sponsor's protocol ID
- NB230001-NCP
- Status last verified
- Nov 2023
- First submitted
- 7 Mar 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05775237
- Acronym / sponsor ID
- NB230001-NCP
- Conditions
- Healthy Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of clinical study
| Arm | Type | Receives |
|---|---|---|
| Curcumin Gummies | Experimental | Dietary Supplement: Curcumin GummiesCurcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin. |
| Vitamin C Gummies | Experimental | Dietary Supplement: Vitamin C GummiesVitamin C Gummies contain Vitamin C and Zinc |
| Multivitamin Gummies | Experimental | Dietary Supplement: Multivitamin GummiesMultivitamin 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 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin GummiesAlso: curcuminChew gummies thoroughly and completely before swallowing. | Dietary supplement | Curcumin Gummies |
| Vitamin C GummiesAlso: Vitamin CChew gummies thoroughly and completely before swallowing. | Dietary supplement | Vitamin C Gummies |
| Multivitamin GummiesAlso: MultivitaminChew gummies thoroughly and completely before swallowing. | Dietary supplement | Multivitamin Gummies |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Chitra Prajapati, MBBS principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin Gummies, Vitamin C Gummies and Multivitamin Gummies in people with Healthy Children, run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Safety (time frame: Day 01 before test product usage to 30 Day after Test product usage). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.