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Abstract: The two phrases that compose the name "Nutraceuticals" are "Nutrition" and "Pharmaceuticals." These are meant to be ingested orally.
Nutrition: Include food or part of food.
Pharmaceuticals: engaged in the manufacture, preparation, dispensing, or sale of drugs.
The concept of nutraceuticals is to put an emphasis on prophylaxis. Hippocrates, a Greek physician, regarded as the father of medicine, said, "Let food be your medicine.”
Nutraceuticals led to new era of medicine, and transformed into a research - oriented sector. It includes mainly 1. herbs, 2. nutrients, 3. diet supplements [1]. Types of foods include dietary fibres, prebiotics, probiotics, PUFAS, antioxidants, spices, health drinks, sports drinks, fortified foods, etc. These are often perceived as "safe" and have minimal side effects. Nowadays, it is a popular and attractive type of system used for the prevention of many types of ailments, as the side effects of allopathic medicines are high. But western medicine is dominating the use of nutraceuticals. Nutraceuticals must also have a place alongside novel forms of medicines despite the fact that evaluating them is a difficult problem given the state of scientific knowledge and regulatory affairs.
Role of placebo-controlled double-blind RCT interventional study decentralised study single crossover trial etc and assessment of safety and efficacy as well as risk-benefit analysis it was important to identify and address deceptive elements especially in the context of nutraceuticals to improve the guidelines applicability and relevance to health promotion we must rethink them additionally these point out the drawbacks and complications of conventional RCT and provide proof of concept the purpose and significance of clinical trials for nutraceuticals are explained in the current paper.
Keywords:
Nutraceuticals, Dietary supplements, Clinical trial, Evidence Based Nutrition, CDSCO, FDA
Cite Article:
"Practical challenges faced in conducting clinical trials for Nutraceuticals and current scenario in US and India", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 7, page no.539 - 544, July-2023, Available :http://www.ijrti.org/papers/IJRTI2307079.pdf
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ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator