Article

Randomized Control Trial to Assess the Efficacy and Safety of NRL/2019/5PNW with Micronutrient Fortification to Promote Health and Well-being in Woman in Fertile Age

Priya Khare1★, Omkar Kulkarni1, Anuj Agrawal1, Gayatri Ganu2, Medha Joshi3, Manjit Sisode4★ Corresponding author

  1. 1Netsurf Research Labs Pvt. Ltd, Baner, Pune, Maharashtra, INDIA.
  2. 2Clinical Research Unit, Mprex Healthcare, Nisarg Plaza, Bhumkar Nagar, Wakad, Pune, Maharashtra, INDIA.
  3. 3Pune District Education Association, Pune College of Ayurveda and Sterling Hospital Research Center, Pune, Maharashtra, INDIA.
  4. 4Janseva Multispecialty Hospital, Old Agra Rd, Deopur, Dhule, Maharashtra,, INDIA.

CORRESPONDENCE

Priya Khare

Netsurf Research Labs Pvt. Ltd, Baner, Pune, Maharashtra, INDIA.

Received: 05-09-2020; Revised: 11-10-2020; Accepted: 25-10-2020.

Volume 10, Issue 4 · pp. 581–585 · PUBLISHED · DOI: 10.5330/ijpi.2020.4.101

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ABSTRACT

Background:Women appear with gender specific nutritional requirements that may affect their well-being. The nutritional requirements are there for women in rural, suburban and urban regions altogether. Objective: Netsurf Communications Pvt. Ltd. has developed the NRL/2019/5PNW for the women to help manage their health and wellness. The current research is designed to assess safety and efficacy of the test product. Methods and Materials: The trial is randomized, controlled prospective clinical trial. In the present study, 110 subjects were screened. Total 100 subjects were considered evaluable cases at the end of the study 1:1 in test and Marketed product treated group. Results: Test product was better in activity than marketed product in improving energy levels of the subjects throughout the day, elevating mood, improving quality of sleep and reducing stress. Improved glycemic control and reduction in total cholesterol levels were significantly reduced in test group which has preventive potential of metabolic diseases. Less events of recurrent UTI/ RTI in test treated group suggestive of improvement in immune status of females. Conclusion: NRL/2019/5PNW is safe and effective in promoting health and wellbeing in females in fertile age.

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    Khare, P., Kulkarni, O., Agrawal, A., Ganu, G., Joshi, M., & Sisode, M. (). Randomized Control Trial to Assess the Efficacy and Safety of NRL/2019/5PNW with Micronutrient Fortification to Promote Health and Well-being in Woman in Fertile Age. International Journal of Pharmaceutical Investigation, 10(4), 581–585. https://doi.org/10.5330/ijpi.2020.4.101