Evaluation of Safety and Efficacy of a Herbal Gummy Formulation in Health, Immunity and Cognition Related Parameters in Children
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in Immunity, cognitive health and quality of life
研究概览
简要总结
This study will be a single centred, open label; two arm randomized, parallel group clinical study to evaluate the safety and efficacy of a polyherbal gummies formulation DRDC/2024/0 in health, immunity, and cognition related parameters in children. One hundred and sixty (120 subjects) will be enrolled in the study, 60 will receive the study product followed by a glass (approx. 200 ml) and 60 will take a glass of milk only two times a day.
Healthy males and female school going children not more than 12 years of age, fulfilling the inclusion & exclusion criteria will be enrolled. Screening/baseline procedures will include medical history, physical examination, and vital signs. Assessment of clinical signs and symptoms, vitals and adverse Events will be done at every follow up visit on 4 weeks, 8 weeks, 12. Response to treatment will be measured by Anthropometry Scale, Wechsler Intelligence Scale for Children IV, Monthly record of school attendance, School performance and subjective parameters such as taste evaluation, Physician’s and Parents’ global evaluation in both the treatment arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Male & female children between 5-12 years of age (both inclusive).
- •Medically stable with no requirement of drugs, or any interventions/procedures or any nutraceutical / health supplement.
- •Children who are willing to drink milk regularly.
- •Parents/ Legally Acceptable Representative of children willing to provide an informed consent.
- •No significant medical or surgical disease/s at the time of screening
- •No history of allergic response to Chyawanprash like products/any ingredients of the Chyawanprash and are not averse to taste of Chyawanprash
- •Willing to come for the follow up visits for evaluation.
排除标准
- •Children with any underlying physical, psychological or surgical condition.
- •Children who are reluctant to drink milk regularly.
- •Children who required use of concomitant medications
- •Children who are currently taking any health supplement/nutraceuticals.
- •Subjects participating in other clinical trials 3 months before recruitment.
结局指标
主要结局
Changes in Immunity, cognitive health and quality of life
时间窗: 90 days
次要结局
- 1. Safety assessment basis incidence of adverse events, serious adverse events, and vitals during the study period.(2. Overall safety and tolerability of product by the physician and participant/parent will be evaluated at the end of the study.)
研究者
Dr Lokeshwari H S
Sri Kalabyraveshwara Swamy Ayurvedic Medical College, Hospital and Research Center