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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Assessment of Safety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This Study is Open-label
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Curcumin Gummies
Curcumin Gummies contain energy, dietary fiber, sugar, total carbohydrate, protein, fat, and curcumin.
干预措施: Curcumin Gummies (Dietary Supplement)
Vitamin C Gummies
Vitamin C Gummies contain Vitamin C and Zinc
干预措施: Vitamin C Gummies (Dietary Supplement)
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
干预措施: Multivitamin Gummies (Dietary Supplement)
结局指标
主要结局
Assessment of Safety
时间窗: 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
时间窗: 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
时间窗: 30 Day after usage of Test product
To evaluate the Organoleptic properties of Test Product by using subject perception questionnaires regarding Test Product
次要结局
未报告次要终点
研究者
Dr Chitra Prajapati
Principal Investigator
NeighbourCare Clinics