Current Status of Clinical Research on Formulations Containing Ashtawarga Group of Plants

The foremost recognized holistic health care system, Ayurveda recommends a variety of plant-based remedies for the treatment and prevention of disease. Due to various factors, including the extinction of vital medicinal plants from the local flora, the market is unable to supply the rising demand for herbal treatments, despite the popularity of these drugs growing day by day. Regardless of being a crucial component of many Ayurvedic formulations, Ashtawarga plants are occasionally available and are frequently replaced by inexpensive adulterants. It is essential to consider the likelihood of a clinical trial for the new medicine as substitution results in adding a new herb in the formulation, creates a new entity, and raises questions about its potential medical applications. From the data analysis and considering the regulatory guidelines, it is quite evident that substitution of any component of a drug due to scarcity or intentionally pushes the drug toward its failure for clinical trials. Although these products may be promoted into the market under some other umbrella, the product fails to fulfill the criteria laid down by national and international regulatory authorities. Due to the lack of availability of Ashtawarga plants, the use of substitutes and their standardization becomes the major hurdle for clinical trials of Ashtawarga-based herbal formulations.