a) Background
Over the last few years, herbal beverages have gained popularity among health-conscious consumers. There is a renewed interest in non-nutritive bioactive compounds in the preventive strategy or risk reduction of diseases especially non-communicable, and lifestyle related. 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 improve the anti-oxidant status and 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 Ocimum sanctum (Tulasi) in enhancing the host defense mechanism and improves energy levels in the healthy population. Synergistic combination of herbal extracts of Ashwagandha and Tulasi are used in Formulations 3A and 3B to test the clinical efficacy.
b) Objective
Primary: To assess the Efficacy of Beverage 3(formulation 3A and formulation 3B) for its anti-stress 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 results of this study were not adequate to demonstrate statistically significant interventional efficacy. The results indicated that both herbal beverage formulations 3 A and 3 B containing Ashwagandha and Tulasi extracts did not demonstrate statistically significant efficacy in reducing stress or anxiety, and improving the immunity amongst healthy subjects as represented by HAM-A scores and serum IgG levels after consuming 300 ml of interventional products for 30 days. Overall, the beverages appeared to be safe and well tolerated by the subjects, as the adverse events were mild and transient.
Further research is recommended to evaluate the higher doses of herbs and/or longer duration of treatment and /or change in the study design to evaluate the anti-stress, and immune enhancing properties of beverages containing Ashwagandha and Tulasi.
e) Publication status (Name & year): Nil
Updated as on: 18 Jul 2022