Pharmaceutico-analytical Standardisation of Gandhakadi Pottali Prepared by Two Methods and Comparative Evaluation of their Antioxidant and Hepatoprotective Activity: A Research Protocol

Introduction: In Ayurveda, various herbs and herbo-mineral preparations are described for the prevention and management of liver diseases. Gandhakadi Pottali is one of the classical Ayurvedic formulations indicated for hepatosplenomegaly (Yakrit-Pliha Vyadhi). For herbal and herbo-mineral formulations to be safe and effective, standardisation is necessary. One of the major challenges in the present scenario is the quality control of these medicines. Although some work has been carried out on the standardisation of its individual constituents, the pharmaceutico-analytical standardisation of Gandhakadi Pottali, along with the evaluation of its antioxidant and hepatoprotective properties, has not yet been studied. Need of the study: The modern line of treatment for hepatotoxicity has certain limitations due to the lack of effective hepatoprotective drugs. Therefore, there is an urgent need to utilise traditional therapies for the prevention and treatment of hepatic disorders. These ancient approaches have potential to ameliorate or reverse liver injury. Aim: To study the pharmaceutico-analytical standardisation of Gandhakadi Pottali prepared by two methods (Bhavana Process and Gandhaka Drava Method) and to carry out a comparative evaluation of their antioxidant and hepatoprotective activities. Materials and Methods: The study design is an in-vitro interventional study, the duration of the study will be 24 months, from April 2023 to April 2025. Gandhakadi Pottali will be prepared by two methods: one mentioned in Rasa Ratna Samucchaya (Bhavana Process) and the other by the Gandhaka Drava Method. Both preparations will be evaluated and compared for their antioxidant and hepatoprotective activities. Pharmaceutical work will be carried out at the Department of Rasa Shastra and Bhaishajya Kalpana, MGACH and RC, Wardha, Maharashtra, India. Analytical work will be conducted at a certified analytical laboratory, VNIT, Nagpur, Maharashtra, India. Experimental work will be carried out at the Central Indian Institute of Medical Sciences (CIIMS), Nagpur, Maharashtra, India. Comparisons between groups will be conducted using the Student’s t-test.