a) Background
One of the predominant causes of global morbidity and mortality is life-style-related chronic diseases, like stress. There is increasing evidence that herbs like Ashwagandha (Withania somnifera) and Guduchi (Tinospora cordifolia) have beneficial effects in the management of physical, chemical, metabolic and psychological stress. Many studies have attested the pre-clinical and clinical efficacy of Ashwagandha and Guduchi, however, this study is a novel attempt to introduce the synergistic combination of both herbs in a beverage form and investigate its efficacy and safety profile in improving energy levels and enhancement of immunity in healthy volunteers.
b) Objective
To assess the Efficacy of Beverage 1(Formulation 1A and Formulation 1B) for its active energy and Immunity properties
c) Total recruitment & no. of sites
A total of 120 healthy volunteers were recruited from 2 sites in India.
d) Conclusion
Overall, the beverages 1A and 1B containing Ashwagandha and Guduchi did not improve either serum cortisol or IgG levels, indicators of active energy and improved immunity respectively. Administration of beverages 1A and 1B did not produce serious adverse effects in healthy subjects. Commonly reported adverse events were transient.
As the beverages were well tolerated by the healthy subjects, and there was some improvement in Serum cortisol & Serum IgG (though not statistically significant) in the interventional groups, further research is recommended to evaluate the efficacy for energy and immunity response with higher doses of herbs and/or longer duration of treatment and/or a modification in study design to assess the energy or immune enhancing properties of beverages containing Ashwagandha and Guduchi.
e) Publication status (Name & year): Nil
Updated as on: 18 Jul 2022