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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin Gummies | Experimental | Curcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin. |
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| Vitamin C Gummies | Experimental | Vitamin C Gummies contain Vitamin C and Zinc |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin Gummies | Dietary Supplement | Chew gummies thoroughly and completely before swallowing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Chitra Prajapati, MBBS | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Pvt Ltd | Gandhinagar | Gujarat | 382421 | India |
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An Open-Label, Three-Arm, Parallel, Investigator-Initiated Trial of clinical study
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This Study is Open-label
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| Vitamin C Gummies | Dietary Supplement | Chew gummies thoroughly and completely before swallowing. |
|
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| Multivitamin Gummies | Dietary Supplement | Chew gummies thoroughly and completely before swallowing. |
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|
| ID | Term |
|---|---|
| D003474 | Curcumin |
| D001205 | Ascorbic Acid |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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