Evaluation of Relative Oral Bioavailability of Shankha bhasma Prepared by Two Different Methods in Healthy Volunteers: A Study Protocol

Abstract

Background: Rastarangini Shankha (Conch Shell) Bhasma is one of the traditional medicines reported to be used for centuries in the treatment of calcium deficiency disorders. It proves to be a good source of calcium. But reports on its bioavailability are hardly available. This study aims to assess the methods of preparation of Shankha Bhasma and assess its relative oral bioavailability in healthy volunteers. Materials and Methods: This study will include preparation of Shankha Bhasma in Rasashastra department. The traditional method will be giving Putas. Another method includes heating Shudhha Shankha on gas flame. The products obtained with these procedures will undergo Bhasma Pariksha that includes organoleptic characteristics, physicochemical parameters,    microbial contamination and other relevant tests. This will be randomized single blind control study of 90 healthy volunteers (30 in each group). The data on oral bioavailability in healthy volunteers will be analyzed by using Pair and unpaired “t” Test, One way ANOVA and descriptive statistics. Results: The relative oral bioavailability of Shankha Bhasma is expected to show all pharmaceutico analytical parameters within normal range and reflect significant effects on healthy volunteers. Conclusion: Significant efficacy of this product directs a new gateway for the management of bioavailability of calcium drugs.