a) Background
Over the last few years, herbal beverages have gained popularity among health-conscious consumers. There is a renewed interest in plant-based bioactive compounds in the preventive strategy or risk reduction of diseases especially non-communicable, and lifestyle related diseases. There is growing evidence that natural bioactive compounds render a number of diversified biological effects, and when consumed as part of a balanced diet, may support the physiological function of body through the anti-oxidant and immunomodulation routes and thus may assist in restoration and enhancing overall health status.
The intended investigational product contains the blend of two herbal constituents, namely, Withania somnifera (Ashwagandha), and Phyllanthus emblica L (Amla) for addressing immunity and management of general health in healthy population.
b) Objective
Primary: To assess the Efficacy of Beverage 2 (Formulation 2A and Formulation 2B) for its General Health Management and Immunity enhancing Properties
Secondary: To assess the Safety and Tolerability of Beverage 2 (Formulation 2A and Formulation 2B)
c) Total recruitment & no. of sites
A total of 120 healthy volunteers were recruited from 2 sites in India.
d) Conclusion
Overall, the beverage formulation 2B containing blend of Ashwagandha and Amla consumed daily @ 300 ml for 30 days significantly improved the Quality of Life scores (p<0>
There was no significant improvement in immune enhancing functions in Interventional groups compared to placebo after adjusting the baseline covariates.
There was no significant improvement in secondary end points including NK cells, POMS, PSSQ in the Interventional Groups compared to placebo.
Administration of beverages 2A and 2B was found to be safe and well tolerated by the healthy subjects.
As the beverages 2A and 2B were well tolerated and there was significant improvement in QoL scores of subjects consuming Formulation 2B, and there were some improvements observed in the other efficacy parameters (though not statistically significant), hence, further research is recommended to evaluate the higher doses of herbs and/or longer duration of treatment and/or a modified study design to assess the immune enhancing properties of beverages containing Ashwagandha and Amla.
e) Publication status (Name & year): Nil
Updated as on: 18 Jul 2022