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Clinical Research in Nutraceuticals

Clinical Research in Nutraceuticals

Dr. Dheeraj Nagore Ph.D. (Pharmaceutical Sciences), MBA, CCRM (Germany)   In India, the number of patients of COVID 19 has mounted exponentially over 15 lakhs, within a period of 3-4 months. In spite of the execution of lockdown procedures including travel bans in India and worldwide, there has been a growing frequency of COVID 19. With an unpredictable burden on the current healthcare system in India, there is an immense need to look at innovation in healthcare both from policy and execution standpoints and should make relevant adaptive changes for short term and long term changed healthcare needs in India.With the improvement in know-how and accessibility of data, the quality and competence of care for the patients have increased in multiple folds in the past few months.

In absence of a bankable treatment to manage the pandemic and time taking and tedious process of vaccine development there should be alternative ways to manage the pandemic situations. Scientific fraternity, healthcare researcher, doctors and even WHOare suggesting keeping individual immunity profile high to combat the COVID 19 situations. But everyone seems to be thinking of treatment after getting infected; I believe working on improving general immunity could be a vital strategy. Nutraceuticals are proven to be the Immunity building blocks.

Nutraceuticals are the combined products providing medicinal values through nutrition. Nutraceuticals are intended to improve the physical health, immunity and fight against stress. Not only Food but Foods for Special Dietary Uses (FSDU) in general can be used by various groups of people. Food for Special Dietary Uses is products used to enhance performance, recovery and maintenance of normal health.

They may include energy nutrients, vitamins, minerals, amino acids, herbs, or botanical extract, energy supplements, supplements that aid in recovery and various other ergogenic aids. Right evaluation of Nutraceutical in COVID 19 situation is really a need of an hour and Clinical Research can be the answer for the same. Clinical research is imperative for determiningnovelNutraceutical for COVID, as well as new ways to reduce the chance of developing this viral infection. Clinical research can show researchers what does and doesn’t work in humans that cannot be learned in the laboratory or in animals. Clinical trials also make clinic insensible to understand the role and decide if the side effects of a Nutraceutical are acceptable when considered against the possible effectiveness in such viral infections.

The benefits and risk profile of any nutraceutical in COVID 19 has to be extracted from wisely designed research protocols which may include with following questions,

  • What is the objective of the study and interventions?
  • What categories of tests and diagnostic parameters are involved?
  • Identifying the right beneficiary group?
  • What are the possible risks, side effects over to benefits of nutraceuticals during treatment?
  • How might this trial affect subject clinical situations?
  • How long will the trial last? Etc.

In most nutraceutical Clinical research, the quality of information and statistics also hardly encounters the standards of rule and regulations. The prominence of measuring relevant objectives and inferences output validated documents should be highlighted. After realizing the need, we have to take major steps forward for proper operations and execution of clinical research in nutraceutical as promising intervention for COVID 19 Pandemic. Definitely along with benefits there will be challenges in this research but we should not forget that the challenges and hurdles are an integral part of any research. As a researcher am assured that the participation of pharmaceutical companies and clinical researcher will bring on novel Nutraceutical interventions in COVID 19.

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