Assessing The Safety Of Nutraceuticals Through A Nutrivigilance Approach And To Develop A Surveillance System For Monitoring Adverse Events Associated With Nutraceuticals
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
研究概览
简要总结
The proposed study introduces a pioneering approach to ensuring the safety of dietary supplements by integrating nutrivigilance principles with cutting-edge surveillance systems. This innovative framework aims to bridge the existing knowledge gap in monitoring adverse events associated with nutraceuticals, thereby enhancing consumer protection and public health through:
1. Integration of Nutrivigilance and Surveillance: The study combines the principles of nutrivigilance with advanced surveillance systems to create a robust framework for monitoring dietary supplement safety.
2. Focus on Adverse Event Monitoring: The research prioritizes the development of a surveillance system specifically designed to track adverse events related to nutraceuticals, addressing a critical need in the current regulatory landscape.
3. Interdisciplinary Approach: The study brings together expertise from nutrition, pharmacovigilance, and public health to create a comprehensive framework for ensuring dietary supplement safety.
4. Potential for Real-World Impact: The proposed surveillance system has the potential to inform regulatory policies, guide industry practices, and ultimately protect consumers from adverse events associated with dietary supplements.
5. Development of a Standardized Framework: The research aims to establish a standardized framework for monitoring dietary supplement safety, which can be adopted by regulatory agencies, industry stakeholders, and researchers worldwide.
6. Potential for Real-World Impact: The proposed surveillance system has the potential to inform regulatory policies, guide industry practices, and ultimately protect consumers from adverse events associated with dietary supplements.
The study employs A mixed-method approach combining quantitative and qualitative methods will be employed. The study will include cross-sectional surveys, real-time adverse event reporting, and stakeholder
interviews to evaluate the implementation and outcomes of the nutrivigilance system.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of all ages, from paediatric to geriatric populations who are willing to enrol into study after filling the informed consent form, who should be available for revisits and follow-ups of minimum 06 months until reaching the required study endpoints will be enrolled.
- •Patient taking nutraceuticals.
排除标准
- •Patients who have not taken the dietary supplement categorized as nutraceuticals as directed by the manufacturer or healthcare professional.
- •Chronic and severely ill patients.
研究者
JIJI K
Sri Adichunchangiri College of Pharmacy