Assessment of safety and efficacy of Nutraceutical supplements/AYUSH medicines in healthy human volunteers.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Safety Assessment, Adverse events, Changes in CBC, LFT, and RFT parameters on screening and day 30.
研究概览
简要总结
Nutraceutical supplements/AYUSH medicines often contain concentrated forms of bioactive compounds or extracts from food sources. Assessing their safety ensures that consumers are not exposed to excessively high levels of these compounds, which could potentially lead to adverse effects. Nutraceutical supplements/AYUSH medicines frequently combine multiple ingredients, sometimes with synergistic or antagonistic effects. Safety assessments help identify potential interactions between these ingredients and evaluate their combined effects on health. Nutraceutical supplements/AYUSH medicines may be formulated to enhance the bioavailability or absorption of specific nutrients or compounds. Safety assessments consider not only the safety of the ingredients themselves but also the safety of any delivery mechanisms or formulation techniques used to improve their effectiveness. Nutraceutical supplements/AYUSH medicines are often marketed for their potential health benefits in addressing specific conditions or promoting overall wellness. Safety assessments help ensure that these products deliver their intended effects without causing harm to consumers. Many Nutraceutical supplements/AYUSH medicines are intended for long-term use to support overall health or manage chronic conditions. Safety assessments provide valuable information about the potential risks associated with prolonged consumption and help establish safe usage guidelines. Nutraceutical supplements/AYUSH medicines may undergo additional processing or extraction steps to isolate active compounds, increasing the importance of safety assessments to ensure the absence of contaminants or adulterants that could compromise product quality. Consumers often perceive Nutraceutical supplements/AYUSH medicines as natural alternatives to pharmaceuticals and expect them to be safe and free from side effects. Rigorous safety assessments help meet these expectations and build trust in the efficacy and safety of Nutraceutical supplements/AYUSH medicines. Nutraceutical supplements/AYUSH medicines are subject to regulations governing their safety, labeling, and marketing claims. Comprehensive safety assessments are essential for regulatory compliance and market authorization, ensuring that products meet established safety standards before they reach consumers. Overall, the assessment of safety in Nutraceutical supplements/AYUSH medicines is essential for ensuring the integrity, efficacy, and safety of these products, meeting consumer expectations, and maintaining regulatory compliance in a rapidly growing and evolving industry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy male and female human trial participants aged between 18 and 60 years (both inclusive);
- •Female trial participants must have a negative urine pregnancy test prior to the housing;
- •Male and females agreeing to use the contraceptive pill or abstinence as a method of contraception during and 07 days after completion of the study;
- •Trial participants in normal health as determined by personal medical history, clinical examination including vital signs, and clinically acceptable results of laboratory examinations (including serological tests).
排除标准
- •1.Incapable of understanding the informed consent information; 2.Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, pulmonary, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities; 3.History or presence of alcoholism or drug abuse; 4.History or presence of cancer; 5.Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinalproducts (including herbal remedies) during the week before study initiation and throughout the study; 6.Major illness during the 90 days before screening; 7.Pregnant women and nursing mothers; 8.Males and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study; 9.Consumption of dietary supplements likely to provide constituents similar to the investigational product in last 3 days.
结局指标
主要结局
Safety Assessment, Adverse events, Changes in CBC, LFT, and RFT parameters on screening and day 30.
时间窗: Screening and day 30.
次要结局
- Efficacy testing by questionnaires.(screening and day 30.)
研究者
Dr V G Vaidya
Lokmanya Medical Research Centre
